Cleared Traditional

K913312 - HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED

K913312 is an FDA 510(k) clearance for HELIX SHAPED COILS WITH DACRON FIBERS, manufactured by Target Therapeutics. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K913312 · Target Therapeutics · Neurology device
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Nov 1991
Decision
106d
Days
Class 2
Risk

K913312 is an FDA 510(k) clearance for the HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Target Therapeutics (San Jose, US). The FDA issued a Cleared decision on November 8, 1991 after a review of 106 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 Target Therapeutics devices

FDA 510(k) Submission Details - K913312

510(k) Number K913312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date November 08, 1991
Days to Decision 106 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 148d · This submission: 106d
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 171
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K913312.
ITC BUNJI PLATINUM EMBOLIZATION COIL
K925523 · Interventional Therapeutics Corp. · Mar 1993
ITC BUNJI COIL (MODIFICATION)
K920324 · Interventional Therapeutics Corp. · Jul 1992
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
K911779 · Target Therapeutics · Nov 1991
ITC BUNJI COIL
K900723 · Interventional Therapeutics Corp. · Feb 1991
HILAL EMBOLIZATION MICROCOIL(TM)
K901337 · Cook, Inc. · Nov 1990
MODIFIED TARGET THERAPEUTICS COILS
K901721 · Target Therapeutics · Jul 1990