The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Pronto V3 Extraction Catheter, Model 5003.
| Device ID | K063371 |
| 510k Number | K063371 |
| Device Name: | PRONTO V3 EXTRACTION CATHETER, MODEL 5003 |
| Classification | Catheter, Embolectomy |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Julie Tapper |
| Correspondent | Julie Tapper VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-08 |
| Decision Date | 2006-12-14 |
| Summary: | summary |