The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for D-stat Dry Silver; D-stat Dry Clear Silver; D-stat Dry Wrap Silver; Thrombix Silver.
| Device ID | K102212 |
| 510k Number | K102212 |
| Device Name: | D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER |
| Classification | Dressing, Wound, Drug |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Lisa Gallatin |
| Correspondent | Lisa Gallatin VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North 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 | Yes |
| Date Received | 2010-08-06 |
| Decision Date | 2011-04-08 |
| Summary: | summary |