Lake Region Manufacturing, Inc.

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Contact: Tom Kleist - VP Marketing & Sales
Web: http://www.lakergn.com
E-Mail:
Address: 340 Lake Hazeltine Dr., Chaska, Minnesota 55318-1034, USA
Phone: +1-(952)-448-5111 | Fax: +1-(952)-448-7012 | Map/Directions >>

Profile: Lake Region Manufacturing, Inc. is an OEM and contract manufacturer of wire formed medical devices and components. We specialize in minimally invasive devices for cardio, endo and neurovascular applications. We manufacture pacing lead coils and precision machined products. We provide an extensive range of medical device manufacturing capabilities ranging from unifilar coiling to implantable machined components to custom assembled and packaged intricate class III devices. Our guide wires offer a balance between tip flexibility and body stiffness. This balance creates excellent tip prolapse while delivering pushability and kink resistance in the body of the guide wire.

The company is ISO 9001 certified.

FDA Registration Number: 2126666

27 Products/Services (Click for related suppliers)

• Angiographic Wire Guide

• Angioplasty Guidewire

• Cables (FDA Code: ISN / 890.3420)

An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

• Compact Phacoemulsification Systems

• Contract Manufacturing

• Coronary Guidewires

• Diagnostic Biliary Catheter (FDA Code: FGE / 876.5010)

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

• Diagnostic Guidewires, Steerable

• Gastro-Urology Catheter & Accessories (FDA Code: KNY / 876.5130)

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Gastro-Urology Stylet (FDA Code: EZB / 876.5130)

• Gastroenterology-Urology Endoscopic Guidewire (FDA Code: OCY / 876.1500)

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980)

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

• Guidewire Catheter (FDA Code: DQX / 870.1330)

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

• Implantable Endocardial Pacemaker Lead

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Mandrel Guidewires

• Nephrostomy Catheter (FDA Code: LJE)

• Neuro Guidewire

• Pacemaker Lead

• Percutaneous Catheter (FDA Code: DQY / 870.1250)

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

• Permanent Cardiac Pacemaker (FDA Code: DTB / 870.3680)

A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

• Phacoemulsification Systems

• Pre-Coat PTFE Guidewires

• Surgical Biliary Catheter (FDA Code: GCA / 876.5010)

• Ultrasonic Phacoemulsification System

• Uncoated Guidewires

• Ureteral Splint (FDA Code: FAD / 876.4620)

A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.