Cleared Traditional

ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM

K061480 · Medtronic, Ireland · Cardiovascular
Aug 2006
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K061480 is an FDA 510(k) clearance for the ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic, Ireland (Shoreview, US). The FDA issued a Cleared decision on August 21, 2006, 83 days after receiving the submission on May 30, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K061480 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2006
Decision Date August 21, 2006
Days to Decision 83 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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