Cleared Traditional

ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT

K123153 · Medtronic, Ireland · Cardiovascular
Apr 2013
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K123153 is an FDA 510(k) clearance for the ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic, Ireland (Galway, IE). The FDA issued a Cleared decision on April 9, 2013, 182 days after receiving the submission on October 9, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K123153 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2012
Decision Date April 09, 2013
Days to Decision 182 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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