Cleared Traditional

K925523 - ITC BUNJI PLATINUM EMBOLIZATION COIL

K925523 is the FDA 510(k) clearance for ITC BUNJI PLATINUM EMBOLIZATION COIL by Interventional Therapeutics Corp.. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K925523 · Interventional Therapeutics Corp. · Neurology device
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Mar 1993
Decision
141d
Days
Class 2
Risk

K925523 is an FDA 510(k) clearance for the ITC BUNJI PLATINUM EMBOLIZATION COIL. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (South San Francisco, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 141 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 Interventional Therapeutics Corp. devices

Submission Details

510(k) Number K925523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1992
Decision Date March 23, 1993
Days to Decision 141 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 148d · This submission: 141d
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 94
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K925523.
BERENSTEIN COIL
K961923 · Target Therapeutics · Aug 1996
GUGLIELMI DETACHABLE COIL
K960705 · Target Therapeutics · May 1996
DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
K951256 · Target Therapeutics · Sep 1995
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