Cleared Special

PRESSURE INJECTABLE PICC

K073451 · Arrow International, Inc. · General Hospital
Jan 2008
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K073451 is an FDA 510(k) clearance for the PRESSURE INJECTABLE PICC, 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 January 15, 2008, 36 days after receiving the submission on December 10, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K073451 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2007
Decision Date January 15, 2008
Days to Decision 36 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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