510(k) K900640 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
| Applicant | 3M Company, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Apr 20, 1990 |
| Received | Feb 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2014 | Terumo Cardiovascular Systems Corp Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass
Item Numbers: 5852, 16010
Product Usage:
This is a Cardioplegia Delivery System that is designed to delivery blood/s Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA
P/N 65246 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE
P/N: 71032 Terminated |
DTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.