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510(k) K053644

THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT by Vascular Solutions, Inc. — Product Code QSX

K053644 is an FDA 510(k) premarket notification submitted by Vascular Solutions, Inc. for the device "THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT". The FDA issued a decision of Substantially Equivalent on February 9, 2006. The device falls under product code QSX (Hemostatic Wound Dressing With Thrombin Or Other Biologics), a Class U device. Vascular Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2006
Date Received
December 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing With Thrombin Or Other Biologics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

To temporarily control bleeding and cover external wounds.

Other clearances by Vascular Solutions, Inc.

  • K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon (May 31, 2024)
  • K230637 — Wattson temporary pacing guidewire (2250) (May 5, 2023)
  • K220647 — GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (August 18, 2022)
  • K221470 — Langston dual lumen catheter (June 17, 2022)
  • K212167 — R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior g (February 9, 2022)
  • K212211 — Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold (February 9, 2022)
  • K210647 — SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcathet (April 30, 2021)
  • K193119 — Twin-Pass Dual Access Catheter (June 29, 2020)
  • K200720 — D-Stat Radial Topical Hemostat (June 26, 2020)
  • K192454 — Wattson Temporary Pacing Guidewire (January 15, 2020)

Other clearances for product code QSX

  • K200720 — D-Stat Radial Topical Hemostat (June 26, 2020)
  • K102212 — D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SIL (April 8, 2011)
  • K092612 — D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 (September 11, 2009)
  • K083190 — D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 (November 12, 2008)
  • K073264 — D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 (December 7, 2007)
  • K072117 — THROMBIX PATCH THROMBIN HEMOSTASIS PATCH (October 5, 2007)
  • K070938 — THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT (August 6, 2007)
  • K063860 — THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT (February 13, 2007)
  • K061219 — D-STAT DRY HEMOSTATIC BANDAGE (October 6, 2006)
  • K053054 — THROMBIX 3X3 HEMOSTATIC PAD (November 23, 2005)

FDA data resources