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510(k) K171931

Celerity ECG Cable Accessory Pack by Medcomp (Medical Components, Inc.) — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2017
Date Received
June 28, 2017
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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  • K153246 — PTFE Super Sheath Introducer 2.1 (February 12, 2016)
  • K141151 — CT MIDLINE (July 8, 2014)
  • K140799 — CELERITY SYSYEM (June 13, 2014)
  • K132498 — VALVED TEARAWAY INTRODUCER GENERATION II (November 25, 2013)

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  • K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (700013 (August 1, 2025)
  • 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)