Product code QSX
- Device name
- Hemostatic Wound Dressing With Thrombin Or Other Biologics
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To temporarily control bleeding and cover external wounds.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200720 | D-Stat Radial Topical Hemostat | Vascular Solutions, LLC | 2020-06-26 |
| K102212 | D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER | Vascular Solutions, Inc. | 2011-04-08 |
| K092612 | D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 | Vascular Solutions, Inc. | 2009-09-11 |
| K083190 | D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 | Vascular Solutions, Inc. | 2008-11-12 |
| K073264 | D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 | Vascular Solutions, Inc. | 2007-12-07 |
| K072117 | THROMBIX PATCH THROMBIN HEMOSTASIS PATCH | Vascular Solutions, Inc. | 2007-10-05 |
| K070938 | THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT | Vascular Solutions, Inc. | 2007-08-06 |
| K063860 | THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT | Vascular Solutions, Inc. | 2007-02-13 |
| K061219 | D-STAT DRY HEMOSTATIC BANDAGE | Vascular Solutions, Inc. | 2006-10-06 |
| K053644 | THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT | Vascular Solutions, Inc. | 2006-02-09 |
| K053054 | THROMBIX 3X3 HEMOSTATIC PAD | Vascular Solutions, Inc. | 2005-11-23 |
| K050511 | THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT | Vascular Solutions, Inc. | 2005-04-14 |
| K050133 | D-STAT RADIAL HEMOSTATIC BAND | Vascular Solutions, Inc. | 2005-02-18 |
| K040510 | VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD | Vascular Solutions, Inc. | 2004-03-17 |
| K040118 | VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC | Vascular Solutions, Inc. | 2004-02-12 |
| K033709 | VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE | Vascular Solutions, Inc. | 2003-12-18 |
| K030836 | D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE | Vascular Solutions, Inc. | 2003-09-17 |
| K012293 | VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT | Vascular Solutions, Inc. | 2002-01-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20841156105584 | D-STAT | TELEFLEX INCORPORATED | 2022-12-15 |
| 10841156105587 | D-STAT | TELEFLEX INCORPORATED | 2022-12-15 |
| 10841156102005 | D-STAT | TELEFLEX INCORPORATED | 2022-12-08 |
| 30841156102009 | D-STAT | TELEFLEX INCORPORATED | 2022-12-08 |
| 20841156105621 | D-STAT | TELEFLEX INCORPORATED | 2022-06-08 |
| 10841156105624 | D-STAT | TELEFLEX INCORPORATED | 2022-06-08 |
| 20841156105577 | D-STAT | TELEFLEX INCORPORATED | 2022-05-25 |
| 10841156105570 | D-STAT | TELEFLEX INCORPORATED | 2022-05-25 |
| 20841156106536 | D-STAT | TELEFLEX INCORPORATED | 2020-07-31 |
| 10841156106539 | D-STAT | TELEFLEX INCORPORATED | 2020-07-31 |
| 30841156101743 | D-STAT | TELEFLEX INCORPORATED | 2019-10-18 |
| 10841156101749 | D-STAT | TELEFLEX INCORPORATED | 2019-10-18 |
| M20630051 | D-Stat® Dry Silver Clear topical hemostat | Vascular Solutions, Inc. | 2016-09-15 |
| M20630061 | D-Stat® Dry Clear topical hemostat | Vascular Solutions, Inc. | 2016-09-15 |
| M20630101 | D-Stat® 2 Dry topical hemostat | Vascular Solutions, Inc. | 2016-09-15 |
| M20635011 | D-Stat® Radial topical hemostat | Vascular Solutions, Inc. | 2016-09-15 |
| M20630050 | D-Stat® Dry Silver Clear topical hemostat | Vascular Solutions, Inc. | 2016-09-15 |
| M20635010 | D-Stat® Radial topical hemostat | Vascular Solutions, Inc. | 2016-09-15 |
| M20630100 | D-Stat® 2 Dry topical hemostat | Vascular Solutions, Inc. | 2016-09-15 |
| M20630060 | D-Stat® Dry Clear topical hemostat | Vascular Solutions, Inc. | 2016-09-15 |