Sentreheart Inc.

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Contact: Leslie Hines - Customer Service Manager
Web: http://www.sentreheart.com
E-Mail:
Address: 300 Saginaw Drive, Redwood, California 94063, USA
Phone: +1-(650)-3541200 | Fax: +1-(650)-3541204 | Map/Directions >>

Profile: Sentreheart Inc. develops & manufactures suture delivery devices. We also offer occlusion balloons and guide wire systems. Our Lariat™ suture delivery device is a remote suture delivery system for placement of a pre-tied suture where tissue approximation or ligation are indicated. It can be introduced through a 4mm access site about the size of a pencil, and capable of closure of anatomic structures as large as 40mm.

The company was founded in 2005.

FDA Registration Number: 3005802238

15 Products/Services (Click for related suppliers)

• Balloon Catheters

• General Surgical Manual Instrument (FDA Code: MDM / 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.

• Guide Wire Systems

• 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.

• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800)

• Occlusion Balloon System

• Occlusion Balloons

• 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.

• Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT / 878.5000)

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

• Pressure Guidewire System

• Single Use Suture Placement Devices

• Steerable (Magnetic) Catheter Or Guidewire System (FDA Code: NDQ / 870.1290)

A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

• Surgical Cutter (FDA Code: FZT / 878.4800)

• Suture Delivery Devices

• Suture Retention Device (FDA Code: KGS / 878.4930)

A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.