Coronary Vein Graft Tag Marker
FDA 510(k) K971966 · Med-Edge, Inc.
510(k) numberK971966
Submission
- Device name
- Coronary Vein Graft Tag Marker
- Applicant
- Med-Edge, Inc.
Clemmons, NC, US - Received
- May 28, 1997
- Decision date
- January 26, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KPK – Marker, Ostia, Aorto-Saphenous Vein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4650
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code KPK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K895369 | Voss Graft MarkerKPK · Traditional | Voss Medical Products | 09/27/1989SE |
| K864919 | Scanlan (TM) Vein/Graft HolderKPK · Traditional | Scanlan Intl., Inc. | 01/12/1987SE |
| K864101 | Cook (R) Vein Graft Ring MarkersKPK · Traditional | Cook, Inc. | 10/30/1986SE |
| K801637 | Fluoro-Mark Radiopaque Anatomical Mkr.KPK · Traditional | C.R. Bard, Inc. | 08/27/1980SE |
| K770802 | Markers, Stainless SteelKPK · Traditional | Cardio-Surgical, Inc. | 06/27/1977SE |
More from Cardio-Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K882314 | Coronary Vein Graft MarkerDSY · Traditional | 08/04/1988SE |
Questions and answers
When was Coronary Vein Graft Tag Marker cleared by the FDA?
Coronary Vein Graft Tag Marker (K971966) received a 510(k) decision of Substantially Equivalent on January 26, 1998, 243 days after the submission was received.
What is the product code of K971966?
The FDA product code is KPK – Marker, Ostia, Aorto-Saphenous Vein, a Class II (moderate risk) device regulated under 21 CFR 878.4650.