510(k) K021830 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Jul 2, 2002 |
| Received | Jun 4, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021830
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.