The following data is part of a premarket notification filed by Synovis Life Technologies, Inc. with the FDA for Vascular Probe, Vascular Probe Es.
| Device ID | K130896 |
| 510k Number | K130896 |
| Device Name: | VASCULAR PROBE, VASCULAR PROBE ES |
| Classification | Dilator, Vessel, Surgical |
| Applicant | SYNOVIS LIFE TECHNOLOGIES, INC. 2575 UNIVERSITY AVE. W. St. Paul, MN 55114 |
| Contact | Stephani K Ayala |
| Correspondent | Stephani K Ayala SYNOVIS LIFE TECHNOLOGIES, INC. 2575 UNIVERSITY AVE. W. St. Paul, MN 55114 |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-01 |
| Decision Date | 2013-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412532696 | K130896 | 000 |
| 50085412532535 | K130896 | 000 |
| 50085412532542 | K130896 | 000 |
| 50085412532559 | K130896 | 000 |
| 50085412532566 | K130896 | 000 |
| 50085412532573 | K130896 | 000 |
| 50085412532580 | K130896 | 000 |
| 50085412532597 | K130896 | 000 |
| 50085412532603 | K130896 | 000 |
| 50085412532610 | K130896 | 000 |
| 50085412532627 | K130896 | 000 |
| 50085412532634 | K130896 | 000 |
| 50085412532641 | K130896 | 000 |
| 50085412532658 | K130896 | 000 |
| 50085412532665 | K130896 | 000 |
| 50085412532672 | K130896 | 000 |
| 50085412532689 | K130896 | 000 |
| 50085412532528 | K130896 | 000 |