D-Stat Radial Topical Hemostat
FDA 510(k) K200720 · Vascular Solutions, LLC
510(k) numberK200720
Submission
- Device name
- D-Stat Radial Topical Hemostat
- Applicant
- Vascular Solutions, LLC
Maple Grove, MN, US - Received
- March 19, 2020
- Decision date
- June 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QSX – Hemostatic Wound Dressing With Thrombin Or Other Biologics
- Device class
- Unclassified
To temporarily control bleeding and cover external wounds.
Other 510(k)s with product code QSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102212 | D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverQSX · Traditional | Vascular Solutions, Inc. | 04/08/2011SE |
| K092612 | D-Stat Rad-Band, Rad-Band, Models 3501, 3505QSX · Special | Vascular Solutions, Inc. | 09/11/2009SE |
| K083190 | D-Stat Dry Wrap Hemostatic Bandage, Model: 3015QSX · Special | Vascular Solutions, Inc. | 11/12/2008SE |
| K073264 | D-Stat Dry Clear Hemostatic Bandage, Model 3005QSX · Special | Vascular Solutions, Inc. | 12/07/2007SE |
| K072117 | Thrombix Patch Thrombin Hemostasis PatchQSX · Traditional | Vascular Solutions, Inc. | 10/05/2007SE |
| K070938 | Thrombi-Paste Thrombin/Gelatin Powder Paste HemostatQSX · Traditional | Vascular Solutions, Inc. | 08/06/2007SE |
| K063860 | Thrombigel Thrombin/Gelatin Foam HemostatQSX · Traditional | Vascular Solutions, Inc. | 02/13/2007SE |
| K061219 | D-Stat Dry Hemostatic BandageQSX · Traditional | Vascular Solutions, Inc. | 10/06/2006SE |
| K053644 | Thrombigel Thrombin/Gelatin Foam HemostatQSX · Traditional | Vascular Solutions, Inc. | 02/09/2006SE |
| K053054 | Thrombix 3X3 Hemostatic PadQSX · Special | Vascular Solutions, Inc. | 11/23/2005SE |
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| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…DQY · Traditional | 02/09/2022SE |
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| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterDQY · Traditional | 08/09/2019SE |
Questions and answers
When was D-Stat Radial Topical Hemostat cleared by the FDA?
D-Stat Radial Topical Hemostat (K200720) received a 510(k) decision of Substantially Equivalent on June 26, 2020, 99 days after the submission was received.
What is the product code of K200720?
The FDA product code is QSX – Hemostatic Wound Dressing With Thrombin Or Other Biologics, a Unclassified device.