Cleared Special

K072526 - MICRUS COURIER ENZO MICROCATHETER 0.0190

K072526 is an FDA 510(k) clearance for MICRUS COURIER ENZO MICROCATHETER 0.0190, manufactured by Micrus Endovascular Corporation. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 28-day FDA review.

K072526 · Micrus Endovascular Corporation · Cardiovascular device
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Oct 2007
Decision
28d
Days
Class 2
Risk

K072526 is an FDA 510(k) clearance for the MICRUS COURIER ENZO MICROCATHETER 0.0190. 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 October 5, 2007 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Micrus Endovascular Corporation devices

FDA 510(k) Submission Details - K072526

510(k) Number K072526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2007
Decision Date October 05, 2007
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K072526.
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
K073585 · Vascular Solutions, Inc. · Apr 2008
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
K073200 · Vascular Solutions, Inc. · Feb 2008
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
K072796 · Concentric Medical, Inc. · Dec 2007
MICRUS COURIER ENZO MICROCATHETER 0.017
K070456 · Micrus Endovascular Corporation · May 2007
DYE MANAGEMENT SYSTEM
K063784 · Icu Medical, Inc. · Apr 2007
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
K062877 · Vascular Solutions, Inc. · Jan 2007