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510(k) K132105

PERCLOT TOPICAL by Cryolife, Inc. — Product Code QSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2014
Date Received
July 8, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing Without 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 Cryolife, Inc.

  • K183635 — PhotoFix Decellularized Bovine Pericardium (February 14, 2019)
  • K172085 — PhotoFix Decellularized Bovine Pericardium (December 4, 2017)
  • K162506 — PhotoFix Decellularized Bovine Pericardium (March 9, 2017)
  • K110581 — PROPATCH SOFT TISSUE REPAIR MATRIX (January 10, 2012)
  • K101587 — PROPATCH SOFT TISSUE REPAIR MATRIX (September 16, 2010)
  • K101866 — CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH (July 23, 2010)
  • K092021 — CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) (May 25, 2010)
  • K091626 — CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH (August 7, 2009)
  • K083106 — CRYOVALVE SG PULMONARY VALVE AND CONDUIT (February 6, 2009)
  • K033484 — HUMAN HEART VALVE, CRYOVALVE SG (February 7, 2008)

Other clearances for product code QSY

  • K251700 — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x (February 26, 2026)
  • K250319 — MFUSE (MS001) (December 15, 2025)
  • K253609 — TRAUMAGEL® 2.0 Hemostatic Gel (December 12, 2025)
  • K240713 — TRAUMAGEL® (August 14, 2024)
  • K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (May 22, 2024)
  • K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) (April 19, 2024)
  • K240454 — RESPONDER® Polysaccharide Hemostat (March 15, 2024)
  • K220525 — RESPONDER Polysaccharide Hemostat (December 4, 2023)
  • K230589 — Celox Rapid X-Ray Gauze (November 17, 2023)
  • K213413 — Hemostatic Dressing (September 1, 2023)