Cleared Special

CG+ ARROW PICC POWERED BY ARROW VPS STYLET

K130876 · Arrow International, Inc. · General Hospital
Apr 2013
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K130876 is an FDA 510(k) clearance for the CG+ ARROW PICC POWERED BY ARROW VPS STYLET, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Arrow International, Inc. (Reading, US). The FDA issued a Cleared decision on April 26, 2013, 28 days after receiving the submission on March 29, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K130876 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2013
Decision Date April 26, 2013
Days to Decision 28 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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