Cleared Special

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS

K153487 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · General Hospital
Feb 2016
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K153487 is an FDA 510(k) clearance for the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS, 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 February 4, 2016, 62 days after receiving the submission on December 4, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K153487 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2015
Decision Date February 04, 2016
Days to Decision 62 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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