The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vascular Solutions Sclero-kit.
| Device ID | K043019 |
| 510k Number | K043019 |
| Device Name: | VASCULAR SOLUTIONS SCLERO-KIT |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Sara L Coon |
| Correspondent | Sara L Coon VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-03 |
| Decision Date | 2004-12-01 |
| Summary: | summary |