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Vision Hollow Fiber Oxygenator with Guardian Coating

by Gish Biomedical, Inc.

510(k) K023381

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 NumberK023381 Date31 Mar 2003ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0519-06 FDA Unclassified (pre-2012) initiated 28 Nov 2005

    Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported.

    • Terminated Z-0730-04 FDA Unclassified (pre-2012) initiated 4 Mar 2004

    Customers reported leakage.

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  • Withdrawn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
DTZ
Device Class
Class II
Regulation
21 CFR Part 870.4350
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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