Company
Terumo Cardiovascular Corporation
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2012 | Terumo Cardiovascular Corporation Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gas Terminated |
DTZ | K993772 |
| Aug 4, 2011 | Terumo Cardiovascular Corporation CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Terminated |
DTN | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Cardiovascular Procedure Kit
X-Coated H/L pack with Cardioplegia, Item # 70067-03 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Cardiovascular Procedure Kit
Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485 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 | K900640 |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Cardiovascular Procedure Kit
X-Coated Pump and Table Pack, Item #71552 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Sarns Cardioplegia Set CPLG BLD MP4 4:1
No recirculation, Item # 16010 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Sarns Cardioplegia Set with Conducer Heat Exchanger Cplg/MP4 4:1, Item # 165720 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375 Terminated |
DTR | None listed |
| Sep 28, 2010 | Terumo Cardiovascular Corporation Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-1642 Terminated |
KFM | K020998 |