Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tempo Temporary Pacing Lead

K-Number: K160260 · 2016-10-25

ApplicantBiotrace Medical, Inc.
Decision Date2016-10-25
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tempo Temporary Pacing Lead is a medical device manufactured by Biotrace Medical, Inc.. It received FDA 510(k) clearance on 2016-10-25 under approval 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. It is manufactured by Biotrace Medical, Inc.. The 510(k) number is K160260.

When was Tempo Temporary Pacing Lead approved by the FDA?

Tempo Temporary Pacing Lead received FDA 510(k) clearance on 2016-10-25, under approval number K160260.

What company makes Tempo Temporary Pacing Lead?

Tempo Temporary Pacing Lead is manufactured by Biotrace Medical, Inc..

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)

K161873Pacel Flow Directed Pacing CatheterSt Jude Medical K161249Streamline 6495 Bipolar Temporary Myocardial Pacing LeadMedtronic K171253Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing LeadMedtronic K173923Temporary Cardiac Pacing WireETHICON, Inc. K190716Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing LeadMedtronic K232261TME Temporary Myocardial ElectrodeOsypka AG

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.

↑