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Performa Adult Hollow Fiber Membrane Oxygenator

by Dideco S.R.L.

510(k) K050447

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 · Special NumberK050447 Date8 Mar 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0768-2012 FDA Unclassified (pre-2012) initiated 2 Dec 2011

    Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.

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  • Withdrawn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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