Cleared Traditional

K944354 - CONTOUR EMBOLI

K944354 is an FDA 510(k) clearance for CONTOUR EMBOLI, manufactured by Interventional Therapeutics Corp.. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K944354 · Interventional Therapeutics Corp. · Neurology device
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Dec 1994
Decision
105d
Days
Class 2
Risk

K944354 is an FDA 510(k) clearance for the CONTOUR EMBOLI. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (Fremont, US). The FDA issued a Cleared decision on December 13, 1994 after a review of 105 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

FDA 510(k) Submission Details - K944354

510(k) Number K944354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1994
Decision Date December 13, 1994
Days to Decision 105 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
43d faster than avg
Panel avg: 148d · This submission: 105d
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 157
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K944354.
GUGLIELMI DETACHABLE COIL
K960705 · Target Therapeutics · May 1996
DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
K951256 · Target Therapeutics · Sep 1995
TRUEFILL PVA PARTICLES
K951314 · Cordis Neurovascular, Inc. · Aug 1995
ITC CONTOUR EMBOLI, MODIFICATION
K914866 · Interventional Therapeutics Corp. · Nov 1993
ITC BUNJI PLATINUM EMBOLIZATION COIL
K925876 · Interventional Therapeutics Corp. · Apr 1993
ITC BUNJI PLATINUM EMBOLIZATION COIL
K925523 · Interventional Therapeutics Corp. · Mar 1993