GRAFT MARKER RING
FDA 510(k) clearance K001915 · decided 2001-04-27
Clearance details
- K-number
- K001915
- Device name
- GRAFT MARKER RING
- Applicant
- T. Korossurgical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-23
- Decision date
- 2001-04-27
- Days to decision
- 308 days
- Clearance type
- Traditional
- Product code
- MAB
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Moorepark, 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 |
|---|---|---|
| SUTURING WASHER (K052642) | First Call, Inc. | 2006-01-17 |
| C.A.B. RING (K894268) | Medi-Sharp, Inc. | 1989-08-17 |
Recalls involving this device
No recalls on record reference this clearance.