FDA 510(k)

MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS

K-Number: K914433 · 1991-12-23

Decision Date1991-12-23

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1991-12-23 under 510(k) number K914433. 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 MDLS 3487/3487A/3587/3587A SCS LEADS?

MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS is a medical device that received FDA 510(k) clearance on 1991-12-23. The listed applicant is Medtronic Vascular. The 510(k) number is K914433.

When did MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS receive FDA 510(k) clearance?

MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS received FDA 510(k) clearance on 1991-12-23, under 510(k) number K914433.

Who is the listed applicant for MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS?

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 MDLS 3487/3487A/3587/3587A SCS LEADS?

The FDA product code for MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS is GZB.

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Official Source

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