SARNS RETROGRADE CANNULA
FDA 510(k) clearance K925442 · decided 1993-05-21
Clearance details
- K-number
- K925442
- Device name
- SARNS RETROGRADE CANNULA
- Applicant
- 3M Health Care, Sarns
- Decision
- Substantially Equivalent
- Date received
- 1992-10-28
- Decision date
- 1993-05-21
- Days to decision
- 205 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 brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, steerable stylet, rib recall (Z-1349-04) | Terumo Cardiovascular Systems Corp | 2004-08-17 |
| Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, malleable stylet, rib recall (Z-1350-04) | Terumo Cardiovascular Systems Corp | 2004-08-17 |
| Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, guidewire stylet, rib recall (Z-1351-04) | Terumo Cardiovascular Systems Corp | 2004-08-17 |
| Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manu recall (Z-1192-03) | Terumo Cardiovascular Systems Corp | 2003-08-29 |
| Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, malleable stylet, ribbed balloon, manu recall (Z-1193-03) | Terumo Cardiovascular Systems Corp | 2003-08-29 |