Decision Date2003-08-08
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ELECTROPHYSIOLOGY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Medical Corp.. It received FDA 510(k) clearance on 2003-08-08 under 510(k) number K030109. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ELECTROPHYSIOLOGY CATHETER?
ELECTROPHYSIOLOGY CATHETER is a medical device that received FDA 510(k) clearance on 2003-08-08. The listed applicant is Alliance Medical Corp.. The 510(k) number is K030109.
When did ELECTROPHYSIOLOGY CATHETER receive FDA 510(k) clearance?
ELECTROPHYSIOLOGY CATHETER received FDA 510(k) clearance on 2003-08-08, under 510(k) number K030109.
Who is the listed applicant for ELECTROPHYSIOLOGY CATHETER?
The FDA 510(k) record lists Alliance Medical Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ELECTROPHYSIOLOGY CATHETER?
The FDA product code for ELECTROPHYSIOLOGY CATHETER is NLH.
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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.