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510(k) K220363

VPS Rhythm DLX Device with TipTracker Technology by Arrow International, LLC (A subsidiary of Teleflex, Inc.) — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2022
Date Received
February 8, 2022
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 Arrow International, LLC (A subsidiary of Teleflex, Inc.)

  • K243599 — Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (March 14, 2025)
  • K242281 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow End (December 20, 2024)
  • K220280 — Arrow Stiffening Stylet (August 30, 2022)

Other clearances for product code LJS

  • K260929 — Neonav ECG Tip Location System (April 17, 2026)
  • K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC (December 16, 2025)
  • K252792 — PM2™ System with ECGuide™ Connector (November 17, 2025)
  • 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)