SUTURING WASHER
FDA 510(k) clearance K052642 · decided 2006-01-17
Clearance details
- K-number
- K052642
- Device name
- SUTURING WASHER
- Applicant
- First Call, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-26
- Decision date
- 2006-01-17
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- MAB
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Derby, CT, 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 |
|---|---|---|
| GRAFT MARKER RING (K001915) | T. Korossurgical Instruments Corp. | 2001-04-27 |
| C.A.B. RING (K894268) | Medi-Sharp, Inc. | 1989-08-17 |
Recalls involving this device
No recalls on record reference this clearance.