Cleared Traditional

K943537 - MODEL 3470 X-TREL RF RECEIVER (FDA 510(k) Clearance)

K943537 · Medtronic Vascular · Neurology device

Apr 1995

Decision

264d

Days

Class 2

Risk

K943537 is an FDA 510(k) clearance for the MODEL 3470 X-TREL RF RECEIVER. This device is classified as a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II - Special Controls, product code GZB).

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on April 12, 1995, 264 days after receiving the submission on July 22, 1994.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.

Submission Details

510(k) Number	K943537 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 22, 1994
Decision Date	April 12, 1995
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GZB — Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 882.5880