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Vector PTA Balloon Dilatation Catheter

by Vector Corporation, LLC

510(k) K143652

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 NumberK143652 Date26 Feb 2015ClearedStatusActive

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  • Withdrawn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, 27 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 Vector PTA Balloon Dilatation Catheter is a high-pressure, non-compliant, coaxial dual lumen over-the-wire balloon catheter. It is indicated for percutaneous transluminal angioplasty of the femoral, iliac, popliteal, and renal arteries, as well as for the treatment of obstructive lesions in native or synthetic arterio-venous dialysis fistulae.

This device is a Class 2 cardiovascular device authorized under FDA 510(k) clearance K143652. It is designed for clinical use in the specified vascular procedures.

Other devices from Vector Corporation, LLC

Questions

AI-generated answers, 27 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 clinical use for the Vector PTA Balloon Dilatation Catheter?

    This device is indicated for percutaneous transluminal angioplasty in the femoral, iliac, popliteal, and renal arteries. It is also used to treat obstructive lesions found in native or synthetic arterio-venous dialysis fistulae.

  • What is the design configuration of this catheter?

    The device is constructed as a high-pressure, non-compliant, coaxial dual lumen over-the-wire balloon catheter, designed specifically for the mechanical requirements of the specified vascular procedures.

  • What is the regulatory status of this device?

    The Vector PTA Balloon Dilatation Catheter is a Class 2 cardiovascular device that has received FDA 510(k) clearance under the number K143652.