510(k) K061527 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Jun 27, 2006 |
| Received | Jun 2, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061527
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.