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FDA 510(k)

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

K-Number: K211223 · 2021-07-21

ApplicantBoston Scientific Corporation
Decision Date2021-07-21
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 2021-07-21 under approval number K211223. 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 2021-07-21. It is manufactured by Boston Scientific Corporation. The 510(k) number is K211223.

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 2021-07-21, under approval number K211223.

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

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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