FDA 510(k)

MEDTRONIC PISCES GENERATION II LEAD KIT

K-Number: K800193 · 1980-02-05

Decision Date1980-02-05

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC PISCES GENERATION II LEAD KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K800193. 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 PISCES GENERATION II LEAD KIT?

MEDTRONIC PISCES GENERATION II LEAD KIT is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Medtronic Vascular. The 510(k) number is K800193.

When did MEDTRONIC PISCES GENERATION II LEAD KIT receive FDA 510(k) clearance?

MEDTRONIC PISCES GENERATION II LEAD KIT received FDA 510(k) clearance on 1980-02-05, under 510(k) number K800193.

Who is the listed applicant for MEDTRONIC PISCES GENERATION II LEAD KIT?

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 PISCES GENERATION II LEAD KIT?

The FDA product code for MEDTRONIC PISCES GENERATION II LEAD KIT 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.