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510(k) K172885

HydroPICC by Access Vascular, Inc. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2018
Date Received
September 21, 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 Access Vascular, Inc.

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  • K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual (March 27, 2025)
  • K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001 (January 17, 2025)
  • K220772 — HydroMID 4F Single Lumen Midline Catheter (December 7, 2022)
  • K213550 — HydroPICC 5F Dual Lumen Catheter (May 4, 2022)
  • K203069 — HydroMID (February 8, 2021)
  • K193015 — HydroPICC (PICC-142) (February 20, 2020)

Other clearances for product code LJS

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  • 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)
  • K233149 — CATHTONG III Tapered PICC Catheter (December 1, 2023)