510(k) K071494 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
| Applicant | Terumo Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Jul 16, 2007 |
| Received | May 30, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071494
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.
FX15RE40 PACK
Product Code:66024 Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended
FX15RE40 PACK
Product Code:66031 Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.
X-COATED FX15RE40 PACK
Product Code: 73484 Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.
X-COATED FX15 ADULT PACK
Product Code: 73399 Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.
Cardiovascular Custom Procedure Kit Adult
Product Co Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.
X-COATED PEDIATRIC 1/4X3/8 RX15 PACK
Product Code: Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK
Product Code: 71062-01
Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit-: CUSTOM X-COATED LOW PRIME
Product Code:72015-03
Manufactured to the design and specifications of the purchaser/user) for the applica Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8
Product Code:72015-04
Manufactured to the design and specifications of the purchaser/user) for the application it is intended Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 x1/2 pack
Product Code:72015-05
Manufactured to the design and specifications of the purchaser/user) for the Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RW30
Product Code:73679
Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Terminated |
DTZ | None listed |
| May 11, 2012 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40
Product Code:73673
Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.