The following data is part of a premarket notification filed by K2 Medical Gmbh & Co. Kg with the FDA for K2 Medical Vascular Clamps.
| Device ID | K120492 |
| 510k Number | K120492 |
| Device Name: | K2 MEDICAL VASCULAR CLAMPS |
| Classification | Clamp, Vascular |
| Applicant | K2 MEDICAL GMBH & CO. KG UNTER BUCHSTEIG 3A Tuttlingen, DE 78532 |
| Contact | Peter Fetzer |
| Correspondent | Peter Fetzer K2 MEDICAL GMBH & CO. KG UNTER BUCHSTEIG 3A Tuttlingen, DE 78532 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-17 |
| Decision Date | 2012-04-30 |
| Summary: | summary |