The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Modification To Vascular Solutions Pronto Extraction Catheter.
| Device ID | K042937 |
| 510k Number | K042937 |
| Device Name: | MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER |
| Classification | Aspiration Thrombectomy Catheter |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Deborah L Neymark |
| Correspondent | Deborah L Neymark VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | QEZ |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-25 |
| Decision Date | 2005-01-31 |
| Summary: | summary |