Cleared Traditional

K080379 - MICRUS MICROCOIL SYSTEM

K080379 is an FDA 510(k) clearance for MICRUS MICROCOIL SYSTEM, 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 138-day FDA review.

K080379 · Micrus Endovascular Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
138d
Days
Class 2
Risk

K080379 is an FDA 510(k) clearance for the MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT. 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 June 30, 2008 after a review of 138 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Micrus Endovascular Corporation devices

FDA 510(k) Submission Details - K080379

510(k) Number K080379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2008
Decision Date June 30, 2008
Days to Decision 138 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
10d faster than avg
Panel avg: 148d · This submission: 138d
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 K080379.
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
K082461 · MicroVention, Inc. · Oct 2008
TRUFILL DCS SYRINGE
K082324 · Cordis Neurovascular, Inc. · Sep 2008
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
K080666 · MicroVention, Inc. · Jul 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 SYSTEMS
K073442 · Micrus Endovascular Corporation · Feb 2008