Low Profile Companion Sheath
K-Number: K223872 · 2023-01-19
ApplicantMerit Medical Systems, Inc.
Decision Date2023-01-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Low Profile Companion Sheath is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-01-19 under approval number K223872. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Low Profile Companion Sheath?
Low Profile Companion Sheath is a medical device that received FDA 510(k) clearance on 2023-01-19. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K223872.
When was Low Profile Companion Sheath approved by the FDA?
Low Profile Companion Sheath received FDA 510(k) clearance on 2023-01-19, under approval number K223872.
What company makes Low Profile Companion Sheath?
Low Profile Companion Sheath is manufactured by Merit Medical Systems, Inc..
What is the FDA product code for Low Profile Companion Sheath?
The FDA product code for Low Profile Companion Sheath is DYB.
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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.