Cleared Special

STEERABLE GUIDE CATHETER

K112239 · Abbott Vascular · Cardiovascular
Aug 2011
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K112239 is an FDA 510(k) clearance for the STEERABLE GUIDE CATHETER, a Catheter, Steerable (Class II — Special Controls, product code DRA), submitted by Abbott Vascular (Menlo Park, US). The FDA issued a Cleared decision on August 31, 2011, 27 days after receiving the submission on August 4, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K112239 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2011
Decision Date August 31, 2011
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRA — Catheter, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1280

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