FDA 510(k)

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

K-Number: K231549 · 2023-06-29

Decision Date2023-06-29

Product CodeOTN

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-06-29 under approval number K231549. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is a medical device that received FDA 510(k) clearance on 2023-06-29. It is manufactured by Boston Scientific Corporation. The 510(k) number is K231549.

When was Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System approved by the FDA?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System received FDA 510(k) clearance on 2023-06-29, under approval number K231549.

What company makes Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is manufactured by Boston Scientific Corporation.

What is the FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

The FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is OTN.

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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.