REDEMPTION Beaming System
K-Number: K221342 · 2022-12-13
ApplicantVilex, LLC
Decision Date2022-12-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
REDEMPTION Beaming System is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2022-12-13 under approval number K221342. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the REDEMPTION Beaming System?
REDEMPTION Beaming System is a medical device that received FDA 510(k) clearance on 2022-12-13. It is manufactured by Vilex, LLC. The 510(k) number is K221342.
When was REDEMPTION Beaming System approved by the FDA?
REDEMPTION Beaming System received FDA 510(k) clearance on 2022-12-13, under approval number K221342.
What company makes REDEMPTION Beaming System?
REDEMPTION Beaming System is manufactured by Vilex, LLC.
What is the FDA product code for REDEMPTION Beaming System?
The FDA product code for REDEMPTION Beaming System is HWC. This falls under the Cardiovascular category.
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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.