Scanlan (TM) Vein/Graft Holder
FDA 510(k) K864919 · Scanlan Intl., Inc.
510(k) numberK864919
Submission
- Device name
- Scanlan (TM) Vein/Graft Holder
- Applicant
- Scanlan Intl., Inc.
Saint Paul, MN, US - Received
- December 16, 1986
- Decision date
- January 12, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K971966 | Coronary Vein Graft Tag MarkerKPK · Traditional | Med-Edge, Inc. | 01/26/1998SE |
| K895369 | Voss Graft MarkerKPK · Traditional | Voss Medical Products | 09/27/1989SE |
| 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 |
|---|---|---|
| K960372 | Scanlan Heifetz Aneurysm Elgiloy Clip SystemHCH · Traditional | 04/26/1996SE |
| K945474 | Scanlan(R) Thoracoscopic Scissors, Clamp, Forceps, Needle HolderGCJ · Traditional | 12/05/1994SE |
| K911184 | Scanlan/Taheri ValvulotomeMGZ · Traditional | 02/18/1992SE |
| K864920 | Scanlan (TM) Instrument TrayFSM · Traditional | 01/12/1987SE |
| K851825 | Scanlan Tunneler, Sheath & TipDWS · Traditional | 07/12/1985SE |
| K841521 | Scanlan EndarsectorDWX · Traditional | 08/03/1984SE |
| K841513 | Scanlan Atraum Instrument Jaw Cover · Traditional | 07/06/1984SE |
| K841085 | Scanlan Colormark Skin MarkerFZZ · Traditional | 06/11/1984SE |
| K841515 | Scanlan Vascu-Statt IIHRG · Traditional | 06/05/1984SE |
| K841514 | Scanlan Vascu-Statt II ApproximatorHRQ · Traditional | 06/05/1984SE |
Questions and answers
When was Scanlan (TM) Vein/Graft Holder cleared by the FDA?
Scanlan (TM) Vein/Graft Holder (K864919) received a 510(k) decision of Substantially Equivalent on January 12, 1987, 27 days after the submission was received.
What is the product code of K864919?
The FDA product code is KPK – Marker, Ostia, Aorto-Saphenous Vein, a Class II (moderate risk) device regulated under 21 CFR 878.4650.