Affinity 61399401079
Affinity 61399401079 is a cardiotomy reservoir (FDA Class II; FDA product code DTN, Reservoir, Blood, Cardiopulmonary Bypass) made by Medtronic, Inc., cleared under FDA 510(k) K935717 on 10 May 1994 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 50613994010792), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number50613994010792 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK935717 | Date10 May 1994 | StatusActive |
Official records
- AccessGUDID record 50613994010792
- FDA 510(k) database K935717
Across registries
- FDA 510(k) K935717 decided 10 May 1994 Active
- FDA GUDID UDI-DI 50613994010792 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K935717
- Listed FDA GUDID 50613994010792
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Affinity
- Generic name
- Cardiotomy reservoir
- Model / reference
- 61399401079
- Primary DI / UDI-DI
- 50613994010792
- 510(k) Number
- FDA product code
- DTN
- GMDN term
- Cardiotomy reservoir
- Device class
- Class II
- Regulation number
- 870.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DTN (RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS).
- XTRA 1/4-20 ft AAL by SORIN GROUP ITALIA SRL
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- Capiox Hardshell Venous Reservoir by TERUMO MEDICAL CORPORATION
- Shiley Cardiotomy Reservoir W/Filter by Shiley, Inc.
- Venous Hardshell Cardiotomy Reservoir, Model VHK 4201 by Jostra AG
- Softshell Venous Reservoir by C. R. Bard, Inc.
- Capiox SX10 Hardshell Reservoir by TERUMO MEDICAL CORPORATION
- NGBCD & NGBCDP Cardioplegia Delivery Systems by Sorin Biomedical, Inc.