Cleared Traditional

ARTLINE

K160448 · Health Line International Corporation · Cardiovascular
Jul 2016
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K160448 is an FDA 510(k) clearance for the ARTLINE, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Health Line International Corporation (Salt Lake City, US). The FDA issued a Cleared decision on July 12, 2016, 145 days after receiving the submission on February 18, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K160448 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2016
Decision Date July 12, 2016
Days to Decision 145 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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