Cleared Traditional

K890061 - MODEL 3586 RESUME LEAD (FDA 510(k) Clearance)

K890061 · Medtronic Vascular · Neurology device

Apr 1990

Decision

476d

Days

Class 2

Risk

K890061 is an FDA 510(k) clearance for the MODEL 3586 RESUME LEAD. 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 30, 1990, 476 days after receiving the submission on January 9, 1989.

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

Submission Details

510(k) Number	K890061 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 09, 1989
Decision Date	April 30, 1990
Days to Decision	476 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	—

Device Classification

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