FDA 510(k)

ALTERNATE SIZE E-Z-PACE ELECTRODE

K-Number: K862298 · 1986-07-11

Decision Date1986-07-11

Product CodeDRO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ALTERNATE SIZE E-Z-PACE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K862298. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALTERNATE SIZE E-Z-PACE ELECTRODE?

ALTERNATE SIZE E-Z-PACE ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Medtronic Vascular. The 510(k) number is K862298.

When did ALTERNATE SIZE E-Z-PACE ELECTRODE receive FDA 510(k) clearance?

ALTERNATE SIZE E-Z-PACE ELECTRODE received FDA 510(k) clearance on 1986-07-11, under 510(k) number K862298.

Who is the listed applicant for ALTERNATE SIZE E-Z-PACE ELECTRODE?

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 ALTERNATE SIZE E-Z-PACE ELECTRODE?

The FDA product code for ALTERNATE SIZE E-Z-PACE ELECTRODE is DRO.

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Related Devices (Code: DRO)

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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.