COALESCENT SURGICAL U-CLIP
FDA 510(k) clearance K013664 · decided 2002-01-24
Clearance details
- K-number
- K013664
- Device name
- COALESCENT SURGICAL U-CLIP
- Applicant
- Coalescent Surgical
- Decision
- Substantially Equivalent
- Date received
- 2001-11-06
- Decision date
- 2002-01-24
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- NCA
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M (K011589) | Bypass , Ltd. | 2001-12-26 |
| SYMMETRY AORTIC CLIP SYSTEM (K003446) | St. Jude Medical Cardiovascular Group, Inc. | 2001-05-21 |
Recalls involving this device
No recalls on record reference this clearance.