The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for D-stat Dry Hemostatic Bandage.
| Device ID | K061219 |
| 510k Number | K061219 |
| Device Name: | D-STAT DRY HEMOSTATIC BANDAGE |
| Classification | Dressing, Wound, Drug |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Julie Tapper |
| Correspondent | Julie Tapper VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-01 |
| Decision Date | 2006-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30841156102009 | K061219 | 000 |