FDA 510(k)

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

K-Number: K190132 · 2019-07-30

Decision Date2019-07-30

Product CodeDRF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K190132. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter?

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Medtronic. The 510(k) number is K190132.

When did Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter receive FDA 510(k) clearance?

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter received FDA 510(k) clearance on 2019-07-30, under 510(k) number K190132.

Who is the listed applicant for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter?

The FDA 510(k) record lists Medtronic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter?

The FDA product code for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is DRF.

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.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITING NCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION NCT07721948Assessment of Catheter Tissue Contact in PFANOT_YET_RECRUITING

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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.