The following data is part of a premarket notification filed by Vesalio with the FDA for Neva Pv Thrombectomy Device.
| Device ID | K201085 |
| 510k Number | K201085 |
| Device Name: | NeVa PV Thrombectomy Device |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | Vesalio 3200 West End Ave, Ste 500 Nashville, TN 37203 |
| Contact | Gustavo Prado |
| Correspondent | Sigi Caron Biologics And Medical Device Consulting Group PO Box 7605 Mammoth Lakes, CA 93546 |
| Product Code | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-23 |
| Decision Date | 2021-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851279008514 | K201085 | 000 |
| 00851279008385 | K201085 | 000 |
| 00851279008392 | K201085 | 000 |
| 00851279008408 | K201085 | 000 |
| 00851279008415 | K201085 | 000 |
| 00851279008422 | K201085 | 000 |
| 00851279008439 | K201085 | 000 |
| 00851279008446 | K201085 | 000 |
| 00851279008453 | K201085 | 000 |
| 00851279008460 | K201085 | 000 |
| 00851279008477 | K201085 | 000 |
| 00851279008484 | K201085 | 000 |
| 00851279008491 | K201085 | 000 |
| 00851279008507 | K201085 | 000 |
| 00851279008378 | K201085 | 000 |