Cleared Traditional

K911433 - RIGHT-ANGLE CATHETER FOR VENTRICULAR DR...

K911433 is an FDA 510(k) clearance for RIGHT-ANGLE CATHETER FOR VENTRICULAR DR..., manufactured by Cordis Corp.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K911433 · Cordis Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
167d
Days
Class 2
Risk

K911433 is an FDA 510(k) clearance for the RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on September 16, 1991 after a review of 167 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

FDA 510(k) Submission Details - K911433

510(k) Number K911433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1991
Decision Date September 16, 1991
Days to Decision 167 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
19d slower than avg
Panel avg: 148d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

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 177
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K911433.
CORDIS STRAIGHT VENTRICULAR CATHETER
K914995 · Cordis Corp. · Mar 1992
CORDIS RIGHT-ANGLE CATHETER GUIDE
K913842 · Cordis Corp. · Feb 1992
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
K913636 · Cordis Corp. · Dec 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
K905860 · Baxter Healthcare Corp · Sep 1991
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
K910938 · Codman & Shurtleff, Inc. · Aug 1991
OPTYX
K904883 · Baxter Healthcare Corp · Jul 1991