The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Pronto V4 Extraction Catheter 5.5f; Pronto V4 Extraction Catheter 6f; Pronto V4 Extraction 7f; Pronto V4 Extraction Cath.
| Device ID | K103405 |
| 510k Number | K103405 |
| Device Name: | PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH |
| Classification | Catheter, Embolectomy |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Matt Nienstedt |
| Correspondent | Matt Nienstedt VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-19 |
| Decision Date | 2010-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20841156108981 | K103405 | 000 |
| 30841156100234 | K103405 | 000 |
| 30841156100241 | K103405 | 000 |
| 30841156100258 | K103405 | 000 |
| M20640050 | K103405 | 000 |
| M20640060 | K103405 | 000 |
| M20640070 | K103405 | 000 |
| M20640080 | K103405 | 000 |
| 20841156108974 | K103405 | 000 |
| 30841156100227 | K103405 | 000 |