Cryovalve Sg Pulmonary Human Heart Valve (and Conduit)

510(k) K092021

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK092021	Date25 May 2010Cleared	StatusActive

5 recalls · 2 ongoing · FDA

- Ongoing Z-2531-2024 FDA Class II initiated 28 May 2024
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
- Ongoing Z-1545-2024 FDA Class II initiated 6 Mar 2024
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
- Terminated Z-0652-2021 FDA Class II initiated 10 Nov 2020
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
- Terminated Z-2271-2018 FDA Class II initiated 14 May 2018
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
- Terminated Z-1560-2011 FDA Unclassified (pre-2012) initiated 17 Feb 2011 on shared 510(k) K092021
Staphylococcus aureus (not methicillin resistant) identified in companion tissue.

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

1 jurisdiction

United States — FDA 510(k) Active

510(k)