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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Epimed International, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) 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. The listed applicant is Epimed International, Inc.. The 510(k) number is K200624.

When did Percutaneous Introducer receive FDA 510(k) clearance?

Percutaneous Introducer received FDA 510(k) clearance on 2020-04-27, under 510(k) number K200624.

Who is the listed applicant for Percutaneous Introducer?

The FDA 510(k) record lists Epimed International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Percutaneous Introducer?

The FDA product code for Percutaneous Introducer is BSO.

Other records listing Epimed International, Inc. as applicant

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Related Devices (Code: BSO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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