Cleared Special

K092702 - MICRUS MICROCATHETER

K092702 is an FDA 510(k) clearance for MICRUS MICROCATHETER, 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 79-day FDA review.

K092702 · Micrus Endovascular Corporation · Cardiovascular device
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Nov 2009
Decision
79d
Days
Class 2
Risk

K092702 is an FDA 510(k) clearance for the MICRUS MICROCATHETER, MODEL COURIER 270. 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 November 20, 2009 after a review of 79 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 - K092702

510(k) Number K092702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2009
Decision Date November 20, 2009
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
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 K092702.
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K092118 · Oscor, Inc. · Jan 2010
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K091961 · Concentric Medical, Inc. · Jul 2009
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
K083922 · Micrus Endovascular Corporation · May 2009
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K090276 · Siemens Medical Solutions USA, Inc. · Feb 2009