Decision Date1984-12-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
CANMED 103 9300 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 1984-12-11 under 510(k) number K844097. 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 CANMED 103 9300 ELECTRODE?
CANMED 103 9300 ELECTRODE is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Medtronic Vascular. The 510(k) number is K844097.
When did CANMED 103 9300 ELECTRODE receive FDA 510(k) clearance?
CANMED 103 9300 ELECTRODE received FDA 510(k) clearance on 1984-12-11, under 510(k) number K844097.
Who is the listed applicant for CANMED 103 9300 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 CANMED 103 9300 ELECTRODE?
The FDA product code for CANMED 103 9300 ELECTRODE is GXY.
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Official Source
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