Cleared Traditional

K901721 - MODIFIED TARGET THERAPEUTICS COILS

K901721 is the FDA 510(k) clearance for MODIFIED TARGET THERAPEUTICS COILS by Target Therapeutics. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K901721 · Target Therapeutics · Neurology device
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Jul 1990
Decision
81d
Days
Class 2
Risk

K901721 is an FDA 510(k) clearance for the MODIFIED TARGET THERAPEUTICS COILS. 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 July 3, 1990 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 Target Therapeutics devices

Submission Details

510(k) Number K901721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1990
Decision Date July 03, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
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.

Device Classification

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 126
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K901721.
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
K911779 · Target Therapeutics · Nov 1991
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
K913312 · Target Therapeutics · Nov 1991
HILAL EMBOLIZATION MICROCOIL(TM)
K901337 · Cook, Inc. · Nov 1990
COIL AND COIL DELIVERY SYSTEM
K891688 · Target Therapeutics · Sep 1989