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510(k) K220971

QuikClot Control+ Hemostatic Dressing by Z-Medica, LLC — Product Code POD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2022
Date Received
April 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporary, Internal Use Hemostatic
Device Class
Class II
Regulation Number
878.4454
Review Panel
SU
Submission Type

Intended to control severely bleeding wounds

Other clearances by Z-Medica, LLC

  • K200167 — QuikClot Control+ (April 23, 2020)
  • K181641 — QuikClot Radial (December 24, 2018)
  • DEN160012 — D2 Dressing (June 30, 2017)
  • K140757 — D2 HEMOSTANTIC DRESSING (July 17, 2014)
  • K123387 — QUIKCLOT HEMOSTATIC DRESSING (April 12, 2013)

Other clearances for product code POD

  • K243553 — QuikClot Control+ Hemostatic Device (March 18, 2025)
  • K213198 — Ax-Surgi Surgical Hemostat (January 5, 2023)
  • K200167 — QuikClot Control+ (April 23, 2020)
  • K183190 — NuStat (September 25, 2019)
  • DEN160012 — D2 Dressing (June 30, 2017)