Cleared Traditional

K904409 - MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER

K904409 is an FDA 510(k) clearance for MEDTRONIC MODEL 3470 X-TREL(TM) RECEIVER, manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with product code GZF cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K904409 · Medtronic Vascular · Neurology device
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Jan 1991
Decision
126d
Days
Class 2
Risk

K904409 is an FDA 510(k) clearance for the MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER. Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 30, 1991 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5870 - 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 Vascular devices

FDA 510(k) Submission Details - K904409

510(k) Number K904409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1990
Decision Date January 30, 1991
Days to Decision 126 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
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZF Device Classification - Class 2, Special Controls

Product Code GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5870
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.