Cleared Special

Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC

K152409 · Navilyst Medical, Inc. · General Hospital
Sep 2015
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K152409 is an FDA 510(k) clearance for the Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on September 24, 2015, 29 days after receiving the submission on August 26, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K152409 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2015
Decision Date September 24, 2015
Days to Decision 29 days
Submission Type Special
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