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510(k) K243553

QuikClot Control+ Hemostatic Device by Teleflex Medical — Product Code POD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2025
Date Received
November 18, 2024
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

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Other clearances for product code POD

  • K213198 — Ax-Surgi Surgical Hemostat (January 5, 2023)
  • K220971 — QuikClot Control+ Hemostatic Dressing (December 14, 2022)
  • K200167 — QuikClot Control+ (April 23, 2020)
  • K183190 — NuStat (September 25, 2019)
  • DEN160012 — D2 Dressing (June 30, 2017)