LimFlow ARC
K-Number: K221541 · 2022-08-31
ApplicantLimFlow, Inc.
Decision Date2022-08-31
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
LimFlow ARC is a medical device manufactured by LimFlow, Inc.. It received FDA 510(k) clearance on 2022-08-31 under approval number K221541. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LimFlow ARC?
LimFlow ARC is a medical device that received FDA 510(k) clearance on 2022-08-31. It is manufactured by LimFlow, Inc.. The 510(k) number is K221541.
When was LimFlow ARC approved by the FDA?
LimFlow ARC received FDA 510(k) clearance on 2022-08-31, under approval number K221541.
What company makes LimFlow ARC?
LimFlow ARC is manufactured by LimFlow, Inc..
What is the FDA product code for LimFlow ARC?
The FDA product code for LimFlow ARC is PDU.
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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.