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510(k) K143238

C3 Wave by Medcomp ( Medical Components) — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2015
Date Received
November 12, 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)

  • K162389 — Medcomp Vessel Dilator (June 1, 2017)
  • K153238 — Dignity Dual Port (March 15, 2016)
  • K132177 — MEDCOMP GEN III POWER INJECTABLE PORT (December 12, 2013)
  • K130897 — MEDCOMP VASCU-PICC WITH VALVE (October 22, 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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  • K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr Hyd (July 1, 2025)
  • K243484 — PM2+ System and SmartPICC Stylet (May 29, 2025)
  • K241587 — pilot TLS (February 26, 2025)
  • K241910 — Neonav ECG Tip Location System (January 19, 2025)
  • 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)