The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for D-stat-dry Hemostatic Bandage; D-stat Radial Hemostatic Bandage.
| Device ID | K030836 |
| 510k Number | K030836 |
| Device Name: | D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE |
| Classification | Dressing, Wound, Drug |
| Applicant | VASCULAR SOLUTIONS, INC. 2495 XENIUM LN. NORTH Minneapolis, MN 55441 |
| Contact | Deborah Jensen |
| Correspondent | Deborah Jensen VASCULAR SOLUTIONS, INC. 2495 XENIUM LN. NORTH Minneapolis, MN 55441 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-03-17 |
| Decision Date | 2003-09-17 |
| Summary: | summary |