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Foxcross .035 PTA Catheter 14 Mm X 20mm X 80 Cm, Model 10342-20, Foxcross .035 PTA Catheter

by Abbott Vascular-Vascular Solutions

510(k) K090509

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 · Special NumberK090509 Date20 Mar 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  • Withdrawn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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 FoxCross .035 PTA Catheter is a peripheral balloon catheter designed for percutaneous transluminal angioplasty (PTA). It is intended to dilate stenotic or occluded arteries in the peripheral vascular system, improving blood flow through narrowed or blocked vessels.

This catheter is supplied as a single-use, non-sterile device and is classified under FDA product code DQY. It measures 14 mm in diameter at the balloon, 20 mm in length, and has an overall length of 80 cm. The device was cleared through the FDA 510(k) pathway as substantially equivalent, with a clearance date of March 20, 2009, under K090509.

Other devices from Abbott Vascular-Vascular Solutions

Questions

AI-generated answers, 19 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 primary use of the FoxCross .035 PTA Catheter in clinical practice?

    The FoxCross .035 PTA Catheter is specifically designed for percutaneous transluminal angioplasty (PTA) in the peripheral vascular system. It is used to dilate narrowed or blocked arteries, restoring blood flow through stenotic or occluded vessels. This makes it ideal for treating peripheral arterial disease (PAD) or other conditions causing arterial stenosis.

  • Is this catheter intended for reuse, or is it meant to be used only once?

    The FoxCross .035 PTA Catheter is explicitly labeled as a single-use device. It is not designed for reuse, which helps ensure patient safety and procedural consistency. Always follow manufacturer guidelines for proper disposal after one-time use.

  • What are the key dimensions of the balloon on this catheter, and how does that affect its application?

    The balloon on the FoxCross .035 PTA Catheter measures 14 mm in diameter and 20 mm in length, making it suitable for treating moderate to large-diameter peripheral arterial lesions. The 80 cm overall length allows for flexibility in navigating through longer vascular pathways, while the .035-inch outer diameter ensures compatibility with standard guidewires used in peripheral interventions.

  • How should this catheter be stored before use, given its non-sterile status?

    Since the FoxCross .035 PTA Catheter is non-sterile, it must be sterilized prior to use using a validated method (e.g., ethylene oxide or gamma irradiation) as specified by the manufacturer. Always follow the supplier’s instructions for sterilization and storage to maintain device integrity and ensure safety. Sterilized catheters should be stored in a clean, dry environment, protected from contamination until ready for use.

  • What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

    The FoxCross .035 PTA Catheter was cleared through the FDA 510(k) pathway, specifically under the Special 510(k) Review classification, with a substantially equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means the device was deemed comparable to a legally marketed predicate device in terms of safety and effectiveness. Clinicians can rely on this clearance as evidence of regulatory review, though individual procedures should still adhere to established clinical guidelines and institutional protocols.