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510(k) K130897

MEDCOMP VASCU-PICC WITH VALVE by Medcomp ( Medical Components) — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2013
Date Received
April 1, 2013
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)

  • K162389 — Medcomp Vessel Dilator (June 1, 2017)
  • K153238 — Dignity Dual Port (March 15, 2016)
  • K143238 — C3 Wave (April 24, 2015)
  • K132177 — MEDCOMP GEN III POWER INJECTABLE PORT (December 12, 2013)
  • K110424 — DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROF (November 30, 2011)
  • K093309 — PRO-LINE CT (BASIC TRAY) MODEL MR28036101 (November 24, 2009)

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  • K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001 (January 17, 2025)
  • K240486 — PM2 System and ECGuide Connector (September 8, 2024)
  • K233149 — CATHTONG III Tapered PICC Catheter (December 1, 2023)