Ruby XL System
K-Number: K250079 · 2025-03-14
ApplicantPenumbra, Inc.
Decision Date2025-03-14
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Ruby XL System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2025-03-14 under approval number K250079. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ruby XL System?
Ruby XL System is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Penumbra, Inc.. The 510(k) number is K250079.
When was Ruby XL System approved by the FDA?
Ruby XL System received FDA 510(k) clearance on 2025-03-14, under approval number K250079.
What company makes Ruby XL System?
Ruby XL System is manufactured by Penumbra, Inc..
What is the FDA product code for Ruby XL System?
The FDA product code for Ruby XL System is KRD.
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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.