The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for D-stat Radial Hemostatic Band.
| Device ID | K050133 |
| 510k Number | K050133 |
| Device Name: | D-STAT RADIAL HEMOSTATIC BAND |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-01-21 |
| Decision Date | 2005-02-18 |
| Summary: | summary |