Cleared Traditional

K063836 - RIVULET VENTRICULAR AND SNAP SHUNT AND ...

K063836 is the FDA 510(k) clearance for RIVULET VENTRICULAR AND SNAP SHUNT AND ... by Medtronic Neurosurgery. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K063836 · Medtronic Neurosurgery · Neurology device
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Aug 2007
Decision
233d
Days
Class 2
Risk

K063836 is an FDA 510(k) clearance for the RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MOD.... Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Cleared decision on August 16, 2007 after a review of 233 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 Medtronic Neurosurgery devices

Submission Details

510(k) Number K063836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2006
Decision Date August 16, 2007
Days to Decision 233 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 148d · This submission: 233d
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 157
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