Cleared Traditional

SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74

K061416 · Medtronic Vascular · Cardiovascular
Oct 2006
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K061416 is an FDA 510(k) clearance for the SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic Vascular (Shoreview, US). The FDA issued a Cleared decision on October 25, 2006, 156 days after receiving the submission on May 22, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K061416 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2006
Decision Date October 25, 2006
Days to Decision 156 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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