Acclarent, Inc.

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Contact: Patrick Fabian - VP National Sales
Web: http://www.acclarent.com
E-Mail:
Address: 1525-B O'Brien Dr., Menlo Park, California 94025, USA
Phone: +1-(650)-687-5888, 877-775-2789 | Fax: +1-(650)-687-5889 | Map/Directions >>

Profile: Acclarent, Inc. focuses on sinus surgery with endoscopic, catheter-based tools; namely Balloon Sinuplasty™ devices. The Balloon Sinuplasty™ system enables otolaryngologists to dilate obstructed sinus ostia in patients suffering from sinusitis. It is based on flexible catheter and wire technology specifically designed to navigate the tortuous sinus anatomy with minimal trauma. Our Relieva Vortex™ sinus irrigation catheter is designed for the challenges associated with flushing tenacious sinus contents. It has side-jet delivery. It combines the power of deep intra-sinus delivery and shear flows to empty the sinus contents.

The company was founded in 2004.

FDA Registration Number: 3005172759

18 Products/Services (Click for related suppliers)

• Balloon Dilation Systems

• Balloon Inflation Devices

• Balloon Sinuplasty Systems

• Bronchoscope Accessories (FDA Code: KTI / 874.4680)

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

• ENT Manual Surgical Instrument (FDA Code: LRC / 874.4420)

• Flexible/Rigid Nasopharyngoscope (FDA Code: EOB / 874.4760)

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

• Iontophoresis Device (FDA Code: EGJ / 890.5525)

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined.

• Microflow Spacers

• Sinus Balloon Catheters

• Sinus Cannula (FDA Code: KAM / 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.

• Sinus Guide Catheter Handles

• Sinus Guide Catheters

• Sinus Guidewires

• Sinus Illumination Systems

• Sinus Irrigation Catheters

• Standard Coronary Sinus Guide Catheters

• Tubing Extension Set

• Tympanostomy Tube (FDA Code: ETD / 874.3880)

A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.