510(k) K081997 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
PERFADEX WITH THAM
| Applicant | Vitrolife Sweden AB, Kungsbacka, SE |
| Decision | Substantially Equivalent, Oct 9, 2008 |
| Received | Jul 14, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081997
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2011 | Vitrolife, Inc. XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs.
Perfadex with THAM kits, Terminated |
MSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.