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FDA 510(k)

iNtuition-Structural Heart Module

K-Number: K191585 · 2019-07-12

ApplicantTerarecon,Inc.
Decision Date2019-07-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iNtuition-Structural Heart Module is a medical device manufactured by Terarecon,Inc.. It received FDA 510(k) clearance on 2019-07-12 under approval number K191585. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iNtuition-Structural Heart Module?

iNtuition-Structural Heart Module is a medical device that received FDA 510(k) clearance on 2019-07-12. It is manufactured by Terarecon,Inc.. The 510(k) number is K191585.

When was iNtuition-Structural Heart Module approved by the FDA?

iNtuition-Structural Heart Module received FDA 510(k) clearance on 2019-07-12, under approval number K191585.

What company makes iNtuition-Structural Heart Module?

iNtuition-Structural Heart Module is manufactured by Terarecon,Inc..

What is the FDA product code for iNtuition-Structural Heart Module?

The FDA product code for iNtuition-Structural Heart Module is LLZ.

Related Clinical Trials

NCT05145426 Investigation of Low-intensity Focused Ultrasound for Human Pain Management COMPLETED NCT06590467 Abbott Structural Heart Device Registry 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.

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