The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Pronto Low Profile (lp) Extraction Catheter, Model 5010.
| Device ID | K072810 |
| 510k Number | K072810 |
| Device Name: | PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 |
| Classification | Catheter, Embolectomy |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Doralie Poganski |
| Correspondent | Doralie Poganski 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 | 2007-10-01 |
| Decision Date | 2007-12-19 |
| Summary: | summary |