FDA 510(k)

XTREL, MODEL NUMBER 3425

K-Number: K883780 · 1988-11-30

Decision Date1988-11-30

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

XTREL, MODEL NUMBER 3425 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1988-11-30 under 510(k) number K883780. 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 XTREL, MODEL NUMBER 3425?

XTREL, MODEL NUMBER 3425 is a medical device that received FDA 510(k) clearance on 1988-11-30. The listed applicant is Medtronic Vascular. The 510(k) number is K883780.

When did XTREL, MODEL NUMBER 3425 receive FDA 510(k) clearance?

XTREL, MODEL NUMBER 3425 received FDA 510(k) clearance on 1988-11-30, under 510(k) number K883780.

Who is the listed applicant for XTREL, MODEL NUMBER 3425?

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 XTREL, MODEL NUMBER 3425?

The FDA product code for XTREL, MODEL NUMBER 3425 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.