Cleared Traditional

CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS) (K960159) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960159 · Cordis Corp. · Neurology device
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Oct 1996
Decision
288d
Days
Class 2
Risk

K960159 is an FDA 510(k) clearance for the CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS). Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on October 25, 1996 after a review of 288 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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 Cordis Corp. devices

Submission Details

510(k) Number K960159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date October 25, 1996
Days to Decision 288 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
140d slower than avg
Panel avg: 148d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - JXG Shunt, Central Nervous System And Components

All 94
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K960159.
CODMAN HAKIM MICRO PRECISION VALVE
K973774 · Johnson & Johnson Professionals, Inc. · Dec 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923 · Johnson & Johnson Professionals, Inc. · Jun 1997
CORDIS SHARP-ENDED STYLET
K955265 · Cordis Corp. · Dec 1996
VENTRICULAR CATHETER SET
K962097 · Cook, Inc. · Aug 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
K955832 · Cordis Corp. · Mar 1996
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
K954021 · Johnson & Johnson Professionals, Inc. · Oct 1995