SIGNATURE(TM) CUSTOM TUBING PACK
FDA 510(k) clearance K924529 · decided 1993-06-23
Clearance details
- K-number
- K924529
- Device name
- SIGNATURE(TM) CUSTOM TUBING PACK
- Applicant
- Avecor Cardiovascular, Inc.
- Decision
- Unknown
- Date received
- 1992-09-08
- Decision date
- 1993-06-23
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Ve recall (Z-0826-2017) | Medtronic Inc | 2016-12-20 |
| Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Ter recall (Z-1023-2016) | Medtronic Perfusion Systems | 2016-02-26 |