Cleared Special

HEARTRAIL III GUIDING CATHETER

K113335 · Terumo Corporation · Cardiovascular
Jul 2012
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K113335 is an FDA 510(k) clearance for the HEARTRAIL III GUIDING CATHETER, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Terumo Corporation (Shibuya-Ku, Tokyo, JP). The FDA issued a Cleared decision on July 16, 2012, 245 days after receiving the submission on November 14, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K113335 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2011
Decision Date July 16, 2012
Days to Decision 245 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200

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