FDA 510(k)

MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL

K-Number: K841584 · 1984-05-14

Decision Date1984-05-14

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1984-05-14 under 510(k) number K841584. 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 RESUME SE-4 3587-LEAD-SPINAL?

MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL is a medical device that received FDA 510(k) clearance on 1984-05-14. The listed applicant is Medtronic Vascular. The 510(k) number is K841584.

When did MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL receive FDA 510(k) clearance?

MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL received FDA 510(k) clearance on 1984-05-14, under 510(k) number K841584.

Who is the listed applicant for MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL?

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 RESUME SE-4 3587-LEAD-SPINAL?

The FDA product code for MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL is GZB.

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Official Source

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