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Bolton PTA Catheter

by Bolton Medical Inc.

510(k) K021996

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021996 Date23 Aug 2002ClearedStatusActive

Official records

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  • Withdrawn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
FDA applicant
Bolton Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 870.1250
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Bolton PTA Catheter is a catheter, angioplasty, peripheral, transluminal device. It is indicated for percutaneous transluminal angioplasty of narrowed or obstructed peripheral arteries such as the iliac, femoral, iliofemoral, renal, popliteal, tibial, tibioperoneal, infrapopliteal, peroneal, and profunda vessels and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The device received FDA 510(k) clearance under K021996 on August 23, 2002, and is classified as a Class II medical device. It is manufactured by Bolton Medical Inc. and is substantially equivalent to predicate devices. No further details regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or additional authorisations are provided in the supplied data.

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