The following data is part of a premarket notification filed by Advanced Vascular Dynamics with the FDA for Compressar Supercomfort Disc And Strongarm Supercomfort System.
| Device ID | K040615 |
| 510k Number | K040615 |
| Device Name: | COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM |
| Classification | Clamp, Vascular |
| Applicant | ADVANCED VASCULAR DYNAMICS 2326 NW EVERETT ST. Portland, OR 97210 |
| Contact | Herbert J Semler |
| Correspondent | Herbert J Semler ADVANCED VASCULAR DYNAMICS 2326 NW EVERETT ST. Portland, OR 97210 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-09 |
| Decision Date | 2004-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815614020248 | K040615 | 000 |
| 10815614020231 | K040615 | 000 |