The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Pronto V3 Extraction Center, Model 5003, Pronto Lp Extraction Catheter, Model 5010, Skyway Rx Support Catheter,.
| Device ID | K083784 |
| 510k Number | K083784 |
| Device Name: | PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, |
| Classification | Catheter, Embolectomy |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Charmaine Sutton |
| Correspondent | Charmaine Sutton 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 | 2008-12-19 |
| Decision Date | 2009-03-30 |
| Summary: | summary |