FDA 510(k)

MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER

K-Number: K904409 · 1991-01-30

Decision Date1991-01-30

Product CodeGZF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1991-01-30 under 510(k) number K904409. 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 MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER?

MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER is a medical device that received FDA 510(k) clearance on 1991-01-30. The listed applicant is Medtronic Vascular. The 510(k) number is K904409.

When did MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER receive FDA 510(k) clearance?

MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER received FDA 510(k) clearance on 1991-01-30, under 510(k) number K904409.

Who is the listed applicant for MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER?

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(R) MODEL 3470 X-TREL(TM) RECEIVER?

The FDA product code for MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER 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.