FDA 510(k)

MEDTRONIC #3484 PISCES EPIDURAL LEAD

K-Number: K812154 · 1981-08-20

Decision Date1981-08-20

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC #3484 PISCES EPIDURAL LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1981-08-20 under 510(k) number K812154. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC #3484 PISCES EPIDURAL LEAD?

MEDTRONIC #3484 PISCES EPIDURAL LEAD is a medical device that received FDA 510(k) clearance on 1981-08-20. The listed applicant is Medtronic Vascular. The 510(k) number is K812154.

When did MEDTRONIC #3484 PISCES EPIDURAL LEAD receive FDA 510(k) clearance?

MEDTRONIC #3484 PISCES EPIDURAL LEAD received FDA 510(k) clearance on 1981-08-20, under 510(k) number K812154.

Who is the listed applicant for MEDTRONIC #3484 PISCES EPIDURAL LEAD?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDTRONIC #3484 PISCES EPIDURAL LEAD?

The FDA product code for MEDTRONIC #3484 PISCES EPIDURAL LEAD is GZB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.