Decision Date2004-09-07
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MODEL 6416 TEMPORARY PACING LEAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2004-09-07 under 510(k) number K042190. 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 MODEL 6416 TEMPORARY PACING LEAD SYSTEM?
MODEL 6416 TEMPORARY PACING LEAD SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-07. The listed applicant is Medtronic Vascular. The 510(k) number is K042190.
When did MODEL 6416 TEMPORARY PACING LEAD SYSTEM receive FDA 510(k) clearance?
MODEL 6416 TEMPORARY PACING LEAD SYSTEM received FDA 510(k) clearance on 2004-09-07, under 510(k) number K042190.
Who is the listed applicant for MODEL 6416 TEMPORARY PACING LEAD SYSTEM?
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 6416 TEMPORARY PACING LEAD SYSTEM?
The FDA product code for MODEL 6416 TEMPORARY PACING LEAD SYSTEM 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.