Cleared Traditional

K061416 - SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74

K061416 is an FDA 510(k) clearance for SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K061416 · Medtronic Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2006
Decision
156d
Days
Class 2
Risk

K061416 is an FDA 510(k) clearance for the SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic Vascular (Shoreview, US). The FDA issued a Cleared decision on October 25, 2006 after a review of 156 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Vascular devices

FDA 510(k) Submission Details - K061416

510(k) Number K061416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 780
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K061416.
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ATB ADVANCED PTA DILATATION CATHETER
K063252 · Cook, Inc. · Nov 2006
OCCLUSION BALLOON
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MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
K062609 · AngioDynamics, Inc. · Oct 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K062594 · Boston Scientific Corporation · Sep 2006