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Owens Catheter

by Boston Scientific

510(k) K896520

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 NumberK896520 Date25 Mar 1991ClearedStatusActive

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  • Withdrawn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
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 870.1250
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Owens Catheter is a peripheral transluminal angioplasty catheter classified as a Class II medical device. It is indicated for use in cardiovascular procedures.

The device received FDA 510(k) clearance (K896520) on March 25, 1991, following a traditional review process. It is manufactured by Boston Scientific Corporation and is supplied as a single-unit device.

Other devices from Boston Scientific

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Questions

AI-generated answers, 24 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 Owens Catheter used for?

    The Owens Catheter is indicated for use in cardiovascular procedures as a peripheral transluminal angioplasty catheter, designed to dilate narrowed or blocked peripheral arteries during angioplasty interventions.

  • How is the Owens Catheter supplied and is it reusable?

    The Owens Catheter is supplied as a single-unit device, meaning it is intended for one-time use only and should not be reprocessed or reused to ensure patient safety and device integrity.

  • Who manufactures the Owens Catheter and where is it made?

    The Owens Catheter is manufactured by Boston Scientific Corporation at their facility located at 2710 Orchard Pkwy, San Jose, CA 95134, United States.