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Bridgepoint Medical Stingray Device And Accessories

by Bridgepoint Medical

510(k) K080987

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK080987 Date6 Feb 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2074-2012 FDA Class II initiated 26 Jun 2012

    BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal. In no case was there any reported adverse clinical event related to the problem.

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  • Withdrawn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, 6 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 Bridgepoint Medical Stingray Device and Accessories is a catheter system designed to facilitate the crossing of chronic total occlusions in coronary and peripheral arteries. It utilizes a re-entry system to navigate and re-enter the true lumen of occluded vessels.

This device is used for directing, steering, controlling, and supporting a guidewire to access target vessels. It has received FDA 510k clearance under the identifier K080987.

Other devices from Bridgepoint Medical

See all devices from Bridgepoint Medical →

Questions

AI-generated answers, 6 Oct 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 purpose of the Bridgepoint Medical Stingray device?

    The Stingray device is a catheter system specifically engineered to facilitate the crossing of chronic total occlusions in both coronary and peripheral arteries by utilizing a re-entry system to navigate back into the true lumen of the vessel.

  • How does the Stingray device assist in guidewire management?

    The device is designed to assist clinicians in directing, steering, controlling, and supporting a guidewire to access target vessels during complex arterial procedures.

  • What is the regulatory status of the Stingray device?

    The Bridgepoint Medical Stingray device and accessories received FDA 510k clearance under the identifier K080987, which indicates it was determined to be substantially equivalent to existing predicate devices.