510(k) K991594 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
| Applicant | Sangstat Medical Corp., Fremont CA, US |
| Decision | Substantially Equivalent, Aug 5, 1999 |
| Received | May 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991594
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2025 | INSTITUT GEORGES LOPEZ Brand Name: Celsior Cold Storage Solution
Product Name: Celsior Cold Storage Solution
Model/Catalog Number: 533682
Product Description: In US Celsior is a class II medical device. Celsior is a clear t Open, Classified |
MSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.