The following data is part of a premarket notification filed by St. Jude Medical Systems Ab with the FDA for Femostop Plys, Femostop Hd, Femostop Compression Arch; Femostop Ii Plus Set; Femostop Ii Plus Arch, Bilateral Adapter; F.
| Device ID | K110193 |
| 510k Number | K110193 |
| Device Name: | FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F |
| Classification | Clamp, Vascular |
| Applicant | ST. JUDE MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE Se-751 35 |
| Contact | Katrin Svensson |
| Correspondent | Katrin Svensson ST. JUDE MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE Se-751 35 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-24 |
| Decision Date | 2011-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734050033 | K110193 | 000 |