Reef HP 0.035 Otw Pta Balloon Dilatation Catheter

FDA 510(k) K092361 · Invatec S.P.A.

Substantially Equivalent

510(k) numberK092361

Submission

Device name
Reef HP 0.035 Otw Pta Balloon Dilatation Catheter
Applicant
Invatec S.P.A.
Bethlehem, PA, US
Received
August 4, 2009
Decision date
October 29, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LIT – Catheter, Angioplasty, Peripheral, Transluminal
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

Other 510(k)s with product code LIT

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K260304WAVE PTA Balloon CatheterLIT · Traditional WAVE Medical AG05/20/2026SE
K252512Armada™ 14 NC PTA CatheterLIT · Traditional Abbott Medical02/13/2026SE
K251915Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional Natec Medical , Ltd.12/18/2025SE
K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special Biotronik, Inc.04/04/2025SE
K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…LIT · Traditional Brosmed Medical Co., Ltd.02/27/2025SE
K241040Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional Natec Medical , Ltd.12/18/2024SE
K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional Creagh Medical Ltd. Dba Surmodics, Inc.11/15/2024SE
K241740Finesse Injectable™ PTA Balloon Dilatation CatheterLIT · Special Summa Therapeutics07/16/2024SE
K241711Oscar Peripheral Multifunctional Catheter systemLIT · Special Biotronik, Inc.07/11/2024SE
K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…LIT · Special Boston Scientific Corporation07/10/2024SE

More from Boston Scientific Corporation

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K100921Admiral Xtreme Pta Balloon Dilatation CatheterLIT · Special 04/30/2010SE
K092352Scuba Biliary Stent SystemFGE · Traditional 03/16/2010SESU
K092177Mo.Ma Ultra Proximal Cerebral Protection Device, Model MUS0130069X6NTE · Traditional 10/15/2009SE

Questions and answers

When was Reef HP 0.035 Otw Pta Balloon Dilatation Catheter cleared by the FDA?

Reef HP 0.035 Otw Pta Balloon Dilatation Catheter (K092361) received a 510(k) decision of Substantially Equivalent on October 29, 2009, 86 days after the submission was received.

What is the product code of K092361?

The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.