Decision Date1984-04-24
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
LUMELEC ELECTRODE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1984-04-24 under 510(k) number K834416. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LUMELEC ELECTRODE CATHETER?
LUMELEC ELECTRODE CATHETER is a medical device that received FDA 510(k) clearance on 1984-04-24. The listed applicant is Cordis Corp.. The 510(k) number is K834416.
When did LUMELEC ELECTRODE CATHETER receive FDA 510(k) clearance?
LUMELEC ELECTRODE CATHETER received FDA 510(k) clearance on 1984-04-24, under 510(k) number K834416.
Who is the listed applicant for LUMELEC ELECTRODE CATHETER?
The FDA 510(k) record lists Cordis Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LUMELEC ELECTRODE CATHETER?
The FDA product code for LUMELEC ELECTRODE CATHETER is LDF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.