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510(k) K223788

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter by Medsource International, LLC — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2023
Date Received
December 19, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Medsource International, LLC

  • K161779 — MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Cath (November 3, 2016)
  • K150611 — MedSource ClearSafe Safety IV Catheter (July 15, 2015)
  • K150333 — MedSource Sharps Dart (May 8, 2015)
  • K140442 — MEDSOURCE SELECTABLE IV SET (April 22, 2014)
  • K140402 — MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS M (April 3, 2014)
  • K131555 — MEDSOURCE IV SAFETY CATHETER (January 31, 2014)
  • K120424 — MEDSOURCE IV ADMINSTRATION SET (July 11, 2012)
  • K080339 — MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) (October 27, 2008)
  • K081516 — MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT (August 26, 2008)

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