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Bridge Occlusion Balloon

by Spectranetics Corporation 2 variants

510(k) K153530

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK153530 Date5 Feb 2016ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2143-2020 FDA Class II initiated 31 Mar 2020

    There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too long it could lead to embolization.

    • Terminated Z-3106-2017 FDA Class I initiated 7 Aug 2017

    Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.

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  • Withdrawn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
MJN
FDA applicant
Spectranetics, Inc.
Device Class
Class II
Regulation
21 CFR Part 870.4450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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