510(k) K823451 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
CLEAR CARDIOPLEJIA DELIVERY SYSTEM
| Applicant | 3M Health Care, Sarns, Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 14, 1983 |
| Received | Nov 17, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823451
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2014 | Terumo Cardiovascular Systems Corp Terumo Cardioplegia Delivery Set-
Item Number: 16130
Product Usage:
The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmona Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
Open Perfusion Pack
P/N 64937 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP & TABLE PACK
P/N 65503/70881-02 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
8:1 CARDIOPLEGIA SET
P/N 70608-01 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED ADULT PRESTIGE PACK
P/N 71544-01 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
ADULT PACK
P/N 71546-01 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
PERFUSION TUBING PACK
P/N 71733 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED HEART/LUNG FRAMEPACK
P/N 71766PP Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED PERFUSION PACK
P/N 71934 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED PUMP AND TABLE PACK W/8:1 CARDIOPLEGIA
P/N 72642 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED MASTER PACK
P/N 72790 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED ADULT PACK
P/N 72846 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
ADULT PACK
P/N: 131351-02 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED HEART - LUNG PACK
P/N: 70608-01 Terminated |
DTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.