The following data is part of a premarket notification filed by Vascular Solutions Llc with the FDA for D-stat Radial Topical Hemostat.
| Device ID | K200720 |
| 510k Number | K200720 |
| Device Name: | D-Stat Radial Topical Hemostat |
| Classification | Dressing, Wound, Drug |
| Applicant | Vascular Solutions LLC 6401 Sycamore Ct N Maple Grove, MN 55369 |
| Contact | Iroquois Ledbeter |
| Correspondent | Melissa Sommerfeld Vascular Solutions LLC 6401 Sycamore Ct N Maple Grove, 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 | 2020-03-19 |
| Decision Date | 2020-06-26 |