The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vascular Solutions D-stat Dry Hemostatic Bandage, The D-stat Radial Hemostatic Band And The D-stat 2 Dry Hemostatic.
| Device ID | K040118 |
| 510k Number | K040118 |
| Device Name: | VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC |
| Classification | Dressing, Wound, Drug |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Gregory W Sachs |
| Correspondent | Gregory W Sachs 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 | 2004-01-20 |
| Decision Date | 2004-02-12 |
| Summary: | summary |