Cleared Traditional

ARROW PRESSURE INJECTABLE PICC

K061289 · Arrow International, Inc. · General Hospital
Aug 2006
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K061289 is an FDA 510(k) clearance for the ARROW 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 August 24, 2006, 107 days after receiving the submission on May 9, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K061289 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2006
Decision Date August 24, 2006
Days to Decision 107 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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