Decision Date1982-04-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
MODEL 3854 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 1982-04-21 under 510(k) number K820876. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MODEL 3854 ELECTRODE?
MODEL 3854 ELECTRODE is a medical device that received FDA 510(k) clearance on 1982-04-21. The listed applicant is Medtronic Vascular. The 510(k) number is K820876.
When did MODEL 3854 ELECTRODE receive FDA 510(k) clearance?
MODEL 3854 ELECTRODE received FDA 510(k) clearance on 1982-04-21, under 510(k) number K820876.
Who is the listed applicant for MODEL 3854 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 MODEL 3854 ELECTRODE?
The FDA product code for MODEL 3854 ELECTRODE is GXY.
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Official Source
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