Cleared Traditional

6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET

K131687 · Medical Components, Inc. · General Hospital
Aug 2013
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K131687 is an FDA 510(k) clearance for the 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on August 16, 2013, 67 days after receiving the submission on June 10, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K131687 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2013
Decision Date August 16, 2013
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

Similar Devices — LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 300
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology
K252373 · Spectrum Vascular · Dec 2025
PM2? System with ECGuide? Connector
K252792 · Piccolo Medical, Inc. · Nov 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr
K243458 · Access Vascular, Inc. · Aug 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
K251212 · Access Vascular, Inc. · Jul 2025
PM2+ System and SmartPICC Stylet
K243484 · Piccolo Medical, Inc. · May 2025
pilot TLS
K241587 · Vygon Corporation · Feb 2025