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FDA 510(k)

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

K-Number: K190132 · 2019-07-30

ApplicantMedtronic
Decision Date2019-07-30
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2019-07-30 under approval 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. It is manufactured by Medtronic. The 510(k) number is K190132.

When was Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter approved by the FDA?

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

What company makes Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter?

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is manufactured by Medtronic.

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

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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.

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