Cleared Traditional

ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS

K113277 · Arrow International, Inc. · General Hospital
Jun 2012
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K113277 is an FDA 510(k) clearance for the ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS, 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 June 21, 2012, 227 days after receiving the submission on November 7, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K113277 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2011
Decision Date June 21, 2012
Days to Decision 227 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

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