The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vascular Solutions Vari-lase Endovenous Laser Procedure Kit.
| Device ID | K050021 |
| 510k Number | K050021 |
| Device Name: | VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Linda Busklein |
| Correspondent | Linda Busklein VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-05 |
| Decision Date | 2005-03-18 |
| Summary: | summary |