Decision Date1981-11-16
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812725. 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 5867-12 BIPOLAR LOW-PROFILE LEAD?
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Medtronic Vascular. The 510(k) number is K812725.
When did MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD receive FDA 510(k) clearance?
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812725.
Who is the listed applicant for MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD?
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 5867-12 BIPOLAR LOW-PROFILE LEAD?
The FDA product code for MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD 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.