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FDA 510(k)

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)

K-Number: K242742 · 2024-10-11

ApplicantSTERIS Corporation
Decision Date2024-10-11
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2024-10-11 under approval number K242742. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) is a medical device that received FDA 510(k) clearance on 2024-10-11. It is manufactured by STERIS Corporation. The 510(k) number is K242742.

When was DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) approved by the FDA?

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) received FDA 510(k) clearance on 2024-10-11, under approval number K242742.

What company makes DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) is manufactured by STERIS Corporation.

What is the FDA product code for DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

The FDA product code for DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) is ODC.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT07596394 A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy). RECRUITING NCT02701283 Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients ACTIVE_NOT_RECRUITING NCT06510855 DurAVR™ THV EU-EFS ACTIVE_NOT_RECRUITING NCT06342635 Hydra Single-centre Experience - Copenhagen, Denmark RECRUITING NCT04302272 STRIVE Post-Market Registry Study RECRUITING

Related PubMed Literature

PMID: 40278172 A Narrative Review of the Evidence for Transcatheter Aortic Valve Implants. Journal of cardiovascular development and disease (2025)

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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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