510(k) K864919
- Device
- SCANLAN (TM) VEIN/GRAFT HOLDER
- Applicant
- SCANLAN INTL., INC.
- 510(k) number
- K864919
- Product code
- KPK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-01-12
- Date received
- 1986-12-16
- Regulation
- 878.4650
- Classification name
- Marker, Ostia, Aorto-saphenous Vein
- Medical specialty
- General & Plastic Surgery
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH R BLAKE
- Address
- One Scanlan Plz. Saint Paul MN US 55107 55107
FDA Registration Numbers#
- 1643116
- 2528981
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971966 | CORONARY VEIN GRAFT TAG MARKER | Med-Edge, Inc. | 1998-01-26 |
| K895369 | VOSS GRAFT MARKER | Voss Medical Products | 1989-09-27 |
| K864101 | COOK (R) VEIN GRAFT RING MARKERS | Cook, Inc. | 1986-10-30 |
| K801637 | FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. | C.R. Bard, Inc. | 1980-08-27 |
| K770802 | MARKERS, STAINLESS STEEL | Cardio-Surgical, Inc. | 1977-06-27 |
Legacy Summary#
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FDA Review#
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