Decision Date2016-10-25
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Tempo Temporary Pacing Lead is the device name listed in this FDA 510(k) record. The listed applicant is Biotrace Medical, Inc.. It received FDA 510(k) clearance on 2016-10-25 under 510(k) number K160260. 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 Tempo Temporary Pacing Lead?
Tempo Temporary Pacing Lead is a medical device that received FDA 510(k) clearance on 2016-10-25. The listed applicant is Biotrace Medical, Inc.. The 510(k) number is K160260.
When did Tempo Temporary Pacing Lead receive FDA 510(k) clearance?
Tempo Temporary Pacing Lead received FDA 510(k) clearance on 2016-10-25, under 510(k) number K160260.
Who is the listed applicant for Tempo Temporary Pacing Lead?
The FDA 510(k) record lists Biotrace Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tempo Temporary Pacing Lead?
The FDA product code for Tempo Temporary Pacing Lead is LDF.
Related Devices (Code: 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.