Cleared Traditional

K891456 - HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM

K891456 is an FDA 510(k) clearance for HEYER-SCHULTE (CSF) VENTRI ACCESS(RESER..., 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 100-day FDA review.

K891456 · Baxter Healthcare Corp · Neurology device
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Jun 1989
Decision
100d
Days
Class 2
Risk

K891456 is an FDA 510(k) clearance for the HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM. 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 June 23, 1989 after a review of 100 days - within the typical 510(k) review window.

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 - K891456

510(k) Number K891456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1989
Decision Date June 23, 1989
Days to Decision 100 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
48d faster than avg
Panel avg: 148d · This submission: 100d
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 220
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K891456.
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR
K896167 · Pudenz-Schulte Medical Research Corp. · Dec 1989
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
K892215 · Codman & Shurtleff, Inc. · Aug 1989
THE PUDENZ IN LINE VALVE
K894072 · Baxter Healthcare Corp · Aug 1989
PMT MODEL 1110-5 PMT PERITONEAL CATHETER
K884036 · Pmt Corp. · Dec 1988
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
K881616 · Progress Mankind Technology · Sep 1988
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
K883114 · Pmt Corp. · Aug 1988