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FDA 510(k)

MODEL 3587A RESUME II LEAD

K-Number: K915540 · 1992-01-22

ApplicantMedtronic Vascular
Decision Date1992-01-22
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 3587A RESUME II 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 1992-01-22 under 510(k) number K915540. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 3587A RESUME II LEAD?

MODEL 3587A RESUME II LEAD is a medical device that received FDA 510(k) clearance on 1992-01-22. The listed applicant is Medtronic Vascular. The 510(k) number is K915540.

When did MODEL 3587A RESUME II LEAD receive FDA 510(k) clearance?

MODEL 3587A RESUME II LEAD received FDA 510(k) clearance on 1992-01-22, under 510(k) number K915540.

Who is the listed applicant for MODEL 3587A RESUME II 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 MODEL 3587A RESUME II LEAD?

The FDA product code for MODEL 3587A RESUME II LEAD is GZF.

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Official Source

View on FDA Database →

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

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