Cleared Special

MitraClip G4 Steerable Guide Catheter

K190167 · Abbott · Cardiovascular
May 2019
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K190167 is an FDA 510(k) clearance for the MitraClip G4 Steerable Guide Catheter, a Catheter, Steerable (Class II — Special Controls, product code DRA), submitted by Abbott (S,Mta Clara, US). The FDA issued a Cleared decision on May 29, 2019, 118 days after receiving the submission on January 31, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K190167 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2019
Decision Date May 29, 2019
Days to Decision 118 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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