Thrombigel Thrombin/Gelatin Foam Hemostat
FDA 510(k) K053644 · Vascular Solutions, Inc.
510(k) numberK053644
Submission
- Device name
- Thrombigel Thrombin/Gelatin Foam Hemostat
- Applicant
- Vascular Solutions, Inc.
Minneapolis, MN, US - Received
- December 30, 2005
- Decision date
- February 9, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|---|
| K200720 | D-Stat Radial Topical HemostatQSX · Special | Vascular Solutions, LLC | 06/26/2020SE |
| 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 |
| K053054 | Thrombix 3X3 Hemostatic PadQSX · Special | Vascular Solutions, Inc. | 11/23/2005SE |
More from Vascular Solutions, Inc.
| 510(k) | Device | Decision |
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| K230637 | Wattson temporary pacing guidewire (2250)DQX · Traditional | 05/05/2023SE |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…DQY · Special | 08/18/2022SE |
| K221470 | Langston dual lumen catheterDQO · Special | 06/17/2022SE |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…DQY · Traditional | 02/09/2022SE |
| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireDQX · Traditional | 02/09/2022SE |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterDQY · Traditional | 04/30/2021SE |
| K193119 | Twin-Pass Dual Access CatheterDQY · Traditional | 06/29/2020SE |
| K200720 | D-Stat Radial Topical HemostatQSX · Special | 06/26/2020SE |
| K192454 | Wattson Temporary Pacing GuidewireDQX · Traditional | 01/15/2020SE |
Questions and answers
When was Thrombigel Thrombin/Gelatin Foam Hemostat cleared by the FDA?
Thrombigel Thrombin/Gelatin Foam Hemostat (K053644) received a 510(k) decision of Substantially Equivalent on February 9, 2006, 41 days after the submission was received.
What is the product code of K053644?
The FDA product code is QSX – Hemostatic Wound Dressing With Thrombin Or Other Biologics, a Unclassified device.