FDA 510(k)

MODEL 3470 X-TREL RF RECEIVER

K-Number: K943537 · 1995-04-12

Decision Date1995-04-12

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MODEL 3470 X-TREL RF 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 1995-04-12 under 510(k) number K943537. 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 MODEL 3470 X-TREL RF RECEIVER?

MODEL 3470 X-TREL RF RECEIVER is a medical device that received FDA 510(k) clearance on 1995-04-12. The listed applicant is Medtronic Vascular. The 510(k) number is K943537.

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

MODEL 3470 X-TREL RF RECEIVER received FDA 510(k) clearance on 1995-04-12, under 510(k) number K943537.

Who is the listed applicant for MODEL 3470 X-TREL RF 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 MODEL 3470 X-TREL RF RECEIVER?

The FDA product code for MODEL 3470 X-TREL RF RECEIVER 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.