The following data is part of a premarket notification filed by Advanced Vascular Dynamics with the FDA for Pressuremate Manual Femoral Access Compression Device.
| Device ID | K090286 |
| 510k Number | K090286 |
| Device Name: | PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE |
| Classification | Clamp, Vascular |
| Applicant | ADVANCED VASCULAR DYNAMICS 1910 NW 23RD PLACE Portland, OR 97210 |
| Contact | Herbert J Semler |
| Correspondent | Herbert J Semler ADVANCED VASCULAR DYNAMICS 1910 NW 23RD PLACE Portland, OR 97210 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-05 |
| Decision Date | 2009-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815614020057 | K090286 | 000 |
| 10815614020064 | K090286 | 000 |