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WATCHDOG Hemostasis Valve Kit

by Boston Scientific

510(k) K172453

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

Recall on shared 510(k) K172453; other models may be affected

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 NumberK172453 Date9 Nov 2017ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1592-2023 FDA Class II initiated 5 Apr 2023 on shared 510(k) K172453
    • Ongoing Z-1593-2023 FDA Class II initiated 5 Apr 2023 on shared 510(k) K172453

    The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
DQX
FDA applicant
Boston Scientific Corporation
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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