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FDA 510(k)

Sphere-9Dx Diagnostic Catheter (AFR-00009)

K-Number: K233433 · 2024-08-07

ApplicantMedtronic
Decision Date2024-08-07
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sphere-9Dx Diagnostic Catheter (AFR-00009) is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2024-08-07 under approval number K233433. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sphere-9Dx Diagnostic Catheter (AFR-00009)?

Sphere-9Dx Diagnostic Catheter (AFR-00009) is a medical device that received FDA 510(k) clearance on 2024-08-07. It is manufactured by Medtronic. The 510(k) number is K233433.

When was Sphere-9Dx Diagnostic Catheter (AFR-00009) approved by the FDA?

Sphere-9Dx Diagnostic Catheter (AFR-00009) received FDA 510(k) clearance on 2024-08-07, under approval number K233433.

What company makes Sphere-9Dx Diagnostic Catheter (AFR-00009)?

Sphere-9Dx Diagnostic Catheter (AFR-00009) is manufactured by Medtronic.

What is the FDA product code for Sphere-9Dx Diagnostic Catheter (AFR-00009)?

The FDA product code for Sphere-9Dx Diagnostic Catheter (AFR-00009) is MTD.

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Related Devices (Code: MTD)

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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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