FDA 510(k)

MEDTRONIC 3625 SCREENER SYSTEM

K-Number: K913442 · 1991-11-22

Decision Date1991-11-22

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC 3625 SCREENER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K913442. 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 3625 SCREENER SYSTEM?

MEDTRONIC 3625 SCREENER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Medtronic Vascular. The 510(k) number is K913442.

When did MEDTRONIC 3625 SCREENER SYSTEM receive FDA 510(k) clearance?

MEDTRONIC 3625 SCREENER SYSTEM received FDA 510(k) clearance on 1991-11-22, under 510(k) number K913442.

Who is the listed applicant for MEDTRONIC 3625 SCREENER SYSTEM?

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 3625 SCREENER SYSTEM?

The FDA product code for MEDTRONIC 3625 SCREENER SYSTEM 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.