Cleared Traditional

K792005 - CSF-CARDIAC/PERITONEAL CATHETER

K792005 is the FDA 510(k) clearance for CSF-CARDIAC/PERITONEAL CATHETER by Pudenz-Schulte Medical Research Corp.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K792005 · Pudenz-Schulte Medical Research Corp. · Neurology device
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Jan 1980
Decision
103d
Days
Class 2
Risk

K792005 is an FDA 510(k) clearance for the CSF-CARDIAC/PERITONEAL CATHETER. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1980 after a review of 103 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 Pudenz-Schulte Medical Research Corp. devices

Submission Details

510(k) Number K792005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1979
Decision Date January 16, 1980
Days to Decision 103 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
45d faster than avg
Panel avg: 148d · This submission: 103d
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 156
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K792005.
H-H BURR HOLE CATHETER SUPPORT
K820311 · Holter-Hausner Intl. · Feb 1982
CSG-FLOW CONTROL VALVE
K803257 · Pudenz-Schulte Medical Research Corp. · Jan 1981
H-H FIFTH VENTRICLE
K800168 · Holter-Hausner Intl. · Jan 1980
CSF-VENTRICULAR CATHETER, STANDARD DES
K792007 · Pudenz-Schulte Medical Research Corp. · Jan 1980
H-H SLOTTED CATHETER-RESERVOIR
K791075 · Holter-Hausner Intl. · Aug 1979
H-H SLOTTED VENTRICULAR CATHETER
K791076 · Holter-Hausner Intl. · Aug 1979