Cleared Traditional

K060116 - MICRUS COURIER MICROCATHETERS

K060116 is an FDA 510(k) clearance for MICRUS COURIER MICROCATHETERS, manufactured by Micrus Endovascular Corporation. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K060116 · Micrus Endovascular Corporation · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2006
Decision
115d
Days
Class 2
Risk

K060116 is an FDA 510(k) clearance for the MICRUS COURIER MICROCATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Micrus Endovascular Corporation (San Jose, US). The FDA issued a Cleared decision on May 12, 2006 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Micrus Endovascular Corporation devices

FDA 510(k) Submission Details - K060116

510(k) Number K060116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2006
Decision Date May 12, 2006
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 319
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K060116.
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K061733 · AngioDynamics, Inc. · Aug 2006
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K061963 · Micrus Endovascular Corporation · Aug 2006
LANGSTON DUAL LUMEN CATHETER
K061565 · Vascular Solutions, Inc. · Aug 2006
ISIGHT IMAGING CATHETER, MODEL 38986
K060175 · Boston Scientific Corp · Mar 2006
MERIT IMPRESS DIAGNOSTIC CATHETER
K053171 · Merit Medical Systems, Inc. · Jan 2006
HOSPIRA CATH LAB CONVENIENCE KITS
K052865 · Icu Medical, Inc. · Dec 2005