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Reef HP 0.035 OTW PTA Balloon Dilatation Catheter

by Invatec S.P.A.

510(k) K092361

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092361 Date29 Oct 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LIT
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The REEF HP 0.035 OTW PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal non-compliant dilatation balloon. It is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The device is supplied as a single-use catheter and is not MRI safe. It has a 5F shaft diameter and is available in various balloon diameters and lengths including 6.0 mm diameter with 40 mm length. The device has received FDA 510(k) clearance with K number K092361 under product code LIT for device class 2.

Other devices from Invatec S.P.A.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the REEF HP 0.035 OTW PTA Balloon Dilatation Catheter used for?

    The REEF HP 0.035 OTW PTA Balloon Dilatation Catheter is designed to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for treating obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

  • How is the REEF HP 0.035 OTW PTA Balloon Dilatation Catheter supplied?

    The device is supplied as a single-use catheter and is not MRI safe. It has a 5F shaft diameter and is available in various balloon diameters and lengths including 6.0 mm diameter with 40 mm length.

  • What regulatory clearance has the REEF HP 0.035 OTW PTA Balloon Dilatation Catheter received?

    The device has received FDA 510(k) clearance with K number K092361 under product code LIT for device class 2, indicating it is substantially equivalent to predicate devices for the intended uses.

  • Can the REEF HP 0.035 OTW PTA Balloon Dilatation Catheter be reused?

    No, the REEF HP 0.035 OTW PTA Balloon Dilatation Catheter is supplied as a single-use device and should not be reused to ensure patient safety and device performance.