CARDIOPULMONARY BYPASS VASCULAR CATHETER
FDA 510(k) clearance K905224 · decided 1991-02-05
Clearance details
- K-number
- K905224
- Device name
- CARDIOPULMONARY BYPASS VASCULAR CATHETER
- Applicant
- 3M Health Care, Sarns
- Decision
- Substantially Equivalent
- Date received
- 1990-11-20
- Decision date
- 1991-02-05
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/ recall (Z-2097-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |
| CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage dur recall (Z-2106-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |