Cleared Traditional

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER

K071538 · Arrow International, Inc. · General Hospital

Aug 2007

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K071538 is an FDA 510(k) clearance for the ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Arrow International, Inc. (Reading, US). The FDA issued a Cleared decision on August 30, 2007, 86 days after receiving the submission on June 5, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K071538 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 2007
Decision Date	August 30, 2007
Days to Decision	86 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200