Cleared Special

K072173 - MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE

Also marketed or referenced as:
CASHMERE-SR, MODEL SRC

K072173 is an FDA 510(k) clearance for MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, manufactured by Micrus Endovascular Corporation. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 60-day FDA review.

K072173 · Micrus Endovascular Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
60d
Days
Class 2
Risk

K072173 is an FDA 510(k) clearance for the MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC. Classified as Device, Neurovascular Embolization (product code HCG), 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 60 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device 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 - K072173

510(k) Number K072173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date October 05, 2007
Days to Decision 60 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

HCG Device Classification - Class 2, Special Controls

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
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 Neurology devices follow this clearance model.

Regulatory Peers - HCG Device, Neurovascular Embolization

All 144
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K072173.
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
K080437 · Micrus Endovascular Corporation · May 2008
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
K080967 · Cordis Neurovascular, Inc. · May 2008
MICRUS MICROCOIL SYSTEMS
K073442 · Micrus Endovascular Corporation · Feb 2008
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
K071962 · Cordis Neurovascular, Inc. · Sep 2007
MODIFICATION TO:CONTOUR SE MICROSPHERES
K071634 · Boston Scientific Corp · Jul 2007
HYDROCOIL EMBOLIC SYSTEM (HES)
K070656 · MicroVention, Inc. · Jun 2007