The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Xl Extraction Catheter.
| Device ID | K112571 |
| 510k Number | K112571 |
| Device Name: | XL EXTRACTION CATHETER |
| 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 | 2011-09-06 |
| Decision Date | 2011-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20650910 | K112571 | 000 |
| M20650900 | K112571 | 000 |
| M20650810 | K112571 | 000 |
| M20650800 | K112571 | 000 |