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510(k) K141151

CT MIDLINE by Medcomp (Medical Components, Inc.) — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2014
Date Received
May 5, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Medcomp (Medical Components, Inc.)

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  • K140799 — CELERITY SYSYEM (June 13, 2014)
  • K132498 — VALVED TEARAWAY INTRODUCER GENERATION II (November 25, 2013)

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