Percutaneous Introducer
K-Number: K200624 · 2020-04-27
ApplicantEpimed International, Inc.
Decision Date2020-04-27
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Percutaneous Introducer is a medical device manufactured by Epimed International, Inc.. It received FDA 510(k) clearance on 2020-04-27 under approval number K200624. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Percutaneous Introducer?
Percutaneous Introducer is a medical device that received FDA 510(k) clearance on 2020-04-27. It is manufactured by Epimed International, Inc.. The 510(k) number is K200624.
When was Percutaneous Introducer approved by the FDA?
Percutaneous Introducer received FDA 510(k) clearance on 2020-04-27, under approval number K200624.
What company makes Percutaneous Introducer?
Percutaneous Introducer is manufactured by Epimed International, Inc..
What is the FDA product code for Percutaneous Introducer?
The FDA product code for Percutaneous Introducer is BSO.
Related Clinical Trials
Other Devices by Epimed International, Inc.
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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.