SCANLAN (TM) VEIN/GRAFT HOLDER
FDA 510(k) clearance K864919 · decided 1987-01-12
Clearance details
- K-number
- K864919
- Device name
- SCANLAN (TM) VEIN/GRAFT HOLDER
- Applicant
- Scanlan Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-16
- Decision date
- 1987-01-12
- Days to decision
- 27 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
- Saint Paul, MN, 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 |
|---|---|---|
| CORONARY VEIN GRAFT TAG MARKER (K971966) | Med-Edge, Inc. | 1998-01-26 |
| VOSS GRAFT MARKER (K895369) | Voss Medical Products | 1989-09-27 |
| 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.