The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Femostop Ii.
| Device ID | K944259 |
| 510k Number | K944259 |
| Device Name: | FEMOSTOP II |
| Classification | Clamp, Vascular |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Contact | Dan Akerfeldt |
| Correspondent | Dan Akerfeldt RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-01 |
| Decision Date | 1995-07-20 |