Cleared Traditional

K934545 - PS MEDICAL DELTA BURR HOLE VALVE

K934545 is an FDA 510(k) clearance for PS MEDICAL DELTA BURR HOLE VALVE, manufactured by Pudenz-Schulte Medical Research Corp.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K934545 · Pudenz-Schulte Medical Research Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
218d
Days
Class 2
Risk

K934545 is an FDA 510(k) clearance for the PS MEDICAL DELTA BURR HOLE VALVE. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Goleta, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 218 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 Pudenz-Schulte Medical Research Corp. devices

FDA 510(k) Submission Details - K934545

510(k) Number K934545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1993
Decision Date April 28, 1994
Days to Decision 218 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
70d slower than avg
Panel avg: 148d · This submission: 218d
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 K934545.
CAMINO VENTRICULAR DRAINAGE SYSTEM
K932769 · Camino Laboratories, Inc. · Mar 1995
PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS)
K935560 · Pmt Corp. · Nov 1994
CORDIS GRAVITY COMPENSATING ACCESSORY
K932429 · Cordis Corp. · Jul 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810 · Cordis Corp. · Mar 1994
VENTRI-CATH
K931989 · Gesco Intl., Inc. · Jul 1993
CAMINO VENTRICULAR ACCESS DEVICE
K930222 · Camino Laboratories, Inc. · Apr 1993