CORONARY VEIN GRAFT TAG MARKER
FDA 510(k) clearance K971966 · decided 1998-01-26
Clearance details
- K-number
- K971966
- Device name
- CORONARY VEIN GRAFT TAG MARKER
- Applicant
- Med-Edge, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-28
- Decision date
- 1998-01-26
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- KPK
- Device class
- 2
- Regulation number
- 878.4650
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Clemmons, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Med-Edge
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VOSS GRAFT MARKER (K895369) | Voss Medical Products | 1989-09-27 |
| SCANLAN (TM) VEIN/GRAFT HOLDER (K864919) | Scanlan Intl., Inc. | 1987-01-12 |
| COOK (R) VEIN GRAFT RING MARKERS (K864101) | Cook, Inc. | 1986-10-30 |
| FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. (K801637) | C.R. Bard, Inc. | 1980-08-27 |
| MARKERS, STAINLESS STEEL (K770802) | Cardio-Surgical, Inc. | 1977-06-27 |
Recalls involving this device
No recalls on record reference this clearance.