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Sensation(Tm) Plus 8FR. 50cc Intra-Aortic Balloon Catheter and Accessories

by Cardiac Assist, Maquet Cardiovascular, LLC

510(k) K112327

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK112327 Date9 Sep 2011ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0311-2025 FDA Class II initiated 17 Sep 2024

    There is discrepant labeling on the inner and outer packaging of the device.

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  • Withdrawn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
DSP
Device Class
Class II
Regulation
21 CFR Part 870.3535
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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