SARNS 8.0 SOFT ARC CANNULA
FDA 510(k) clearance K834134 · decided 1984-04-17
Clearance details
- K-number
- K834134
- Device name
- SARNS 8.0 SOFT ARC CANNULA
- Applicant
- 3M Health Care, Sarns
- Decision
- Substantially Equivalent
- Date received
- 1983-11-30
- Decision date
- 1984-04-17
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: T recall (Z-2098-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |