Cleared Special

CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

K153423 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · General Hospital
Jan 2016
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K153423 is an FDA 510(k) clearance for the CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on January 28, 2016, 64 days after receiving the submission on November 25, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K153423 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2015
Decision Date January 28, 2016
Days to Decision 64 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

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