Cleared Traditional

K073442 - MICRUS MICROCOIL SYSTEMS

K073442 is an FDA 510(k) clearance for MICRUS MICROCOIL SYSTEMS, manufactured by Micrus Endovascular Corporation. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K073442 · Micrus Endovascular Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
81d
Days
Class 2
Risk

K073442 is an FDA 510(k) clearance for the MICRUS MICROCOIL SYSTEMS. 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 February 26, 2008 after a review of 81 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micrus Endovascular Corporation devices

FDA 510(k) Submission Details - K073442

510(k) Number K073442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2007
Decision Date February 26, 2008
Days to Decision 81 days
Submission Type Traditional
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
67d faster than avg
Panel avg: 148d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K073442.
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
K080379 · Micrus Endovascular Corporation · Jun 2008
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 SYSTEM CASHMERE-CERECYTE, MODEL CRC
K072173 · Micrus Endovascular Corporation · Oct 2007
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