The following data is part of a premarket notification filed by Advanced Vascular Dynamics with the FDA for Zephyr Vascular Compression Device.
| Device ID | K151363 |
| 510k Number | K151363 |
| Device Name: | Zephyr Vascular Compression Device |
| Classification | Clamp, Vascular |
| Applicant | ADVANCED VASCULAR DYNAMICS 4252 SE INTERNATIONAL WAY, STE. F Milwaukie, OR 97222 |
| Contact | Matthew Semler |
| Correspondent | Matthew Semler ADVANCED VASCULAR DYNAMICS 4252 SE INTERNATIONAL WAY, STE. F Milwaukie, OR 97222 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-21 |
| Decision Date | 2015-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815614020429 | K151363 | 000 |
| 30815614020730 | K151363 | 000 |
| 30815614020747 | K151363 | 000 |
| 30815614020754 | K151363 | 000 |
| 30815614020761 | K151363 | 000 |
| 30815614020778 | K151363 | 000 |
| 30815614020785 | K151363 | 000 |
| 30815614020792 | K151363 | 000 |
| 10815614020958 | K151363 | 000 |
| 20815614020863 | K151363 | 000 |
| 20815614020870 | K151363 | 000 |
| 20815614020375 | K151363 | 000 |
| 20815614020382 | K151363 | 000 |
| 20815614020399 | K151363 | 000 |
| 20815614020405 | K151363 | 000 |
| 20815614020412 | K151363 | 000 |
| 30815614020723 | K151363 | 000 |