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Blower/Mister

by Cardiothoracic Systems, Inc.

510(k) K983135

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 NumberK983135 Date13 Nov 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0983-2019 FDA Class II initiated 24 Jan 2019

    Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

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  • Withdrawn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
FQH
Device Class
Class II
Regulation
21 CFR Part 880.5475
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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