Cleared Traditional

K881491 - MODEL 3487A PISCES EPIDURAL LEAD (FDA 510(k) Clearance)

K881491 · Medtronic Vascular · Neurology device

May 1988

Decision

47d

Days

Class 2

Risk

K881491 is an FDA 510(k) clearance for the MODEL 3487A PISCES EPIDURAL 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 May 25, 1988, 47 days after receiving the submission on April 8, 1988.

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

Submission Details

510(k) Number	K881491 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 08, 1988
Decision Date	May 25, 1988
Days to Decision	47 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