Cleared Traditional

ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM

K053431 · Medtronic, Ireland · Cardiovascular
Mar 2006
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K053431 is an FDA 510(k) clearance for the ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic, Ireland (Shoreview, US). The FDA issued a Cleared decision on March 16, 2006, 97 days after receiving the submission on December 9, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K053431 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2005
Decision Date March 16, 2006
Days to Decision 97 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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