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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 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 Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: LDF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)Medtronic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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