Cleared Traditional

K905860 - HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION

K905860 is an FDA 510(k) clearance for HEYER-SCHULTE SPINAL CYST CATHETER/MODI..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K905860 · Baxter Healthcare Corp · Neurology device
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Sep 1991
Decision
263d
Days
Class 2
Risk

K905860 is an FDA 510(k) clearance for the HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 263 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K905860

510(k) Number K905860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1990
Decision Date September 10, 1991
Days to Decision 263 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
115d slower than avg
Panel avg: 148d · This submission: 263d
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 223
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K905860.
CORDIS RIGHT-ANGLE CATHETER GUIDE
K913842 · Cordis Corp. · Feb 1992
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
K913636 · Cordis Corp. · Dec 1991
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
K911433 · Cordis Corp. · Sep 1991
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
K910938 · Codman & Shurtleff, Inc. · Aug 1991
OPTYX
K904883 · Baxter Healthcare Corp · Jul 1991
PS MEDICAL BUTTON VALVE
K911410 · Pudenz-Schulte Medical Research Corp. · Jun 1991