The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for D-stat Dry Clear Hemostatic Bandage, Model 3005.
| Device ID | K073264 |
| 510k Number | K073264 |
| Device Name: | D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 |
| Classification | Dressing, Wound, Drug |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | James Chapman |
| Correspondent | James Chapman 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 | 2007-11-20 |
| Decision Date | 2007-12-07 |
| Summary: | summary |