Cleared Traditional

K904409 - MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER (FDA 510(k) Clearance)

K904409 · Medtronic Vascular · Neurology device

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. This device is classified as a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II - Special Controls, product code GZF).

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 30, 1991, 126 days after receiving the submission on September 26, 1990.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5870.

Submission Details

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	—

Device Classification

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