Marker, Ostia, Aorto-Saphenous Vein
This device is an aorto-saphenous vein ostia marker used during cardiovascular surgery to identify and mark the openings of saphenous vein grafts at the aorta, facilitating accurate graft placement. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPK, regulated under 21 CFR 878.4650, and is reviewed under the Cardiovascular panel within the General and Plastic Surgery specialty. This device is designated as an implant, as it is placed within the body during cardiac surgery.
Basic Information
- Product Code
- KPK
- Device Class
- FDA class 2
- Regulation Number
- 878.4650
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971966 | CORONARY VEIN GRAFT TAG MARKER | Jan 26, 1998 | Substantially Equivalent | MED-EDGE, INC. |
| K895369 | VOSS GRAFT MARKER | Sep 27, 1989 | Substantially Equivalent | VOSS MEDICAL PRODUCTS |
| K864919 | SCANLAN (TM) VEIN/GRAFT HOLDER | Jan 12, 1987 | Substantially Equivalent | SCANLAN INTL., INC. |
| K864101 | COOK (R) VEIN GRAFT RING MARKERS | Oct 30, 1986 | Substantially Equivalent | COOK, INC. |
| K801637 | FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. | Aug 27, 1980 | Substantially Equivalent | C.R. BARD, INC. |
| K770802 | MARKERS, STAINLESS STEEL | Jun 27, 1977 | Substantially Equivalent | CARDIO-SURGICAL, INC. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.