Cleared Special

Steerable Guide Catheter

K161985 · Abbott Vascular · Cardiovascular
Aug 2016
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K161985 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 (S,Mta Clara, US). The FDA issued a Cleared decision on August 7, 2016, 19 days after receiving the submission on July 19, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K161985 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2016
Decision Date August 07, 2016
Days to Decision 19 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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