Abiomed 23 Fr Sheath
K-Number: K201116 · 2020-06-15
ApplicantAbiomed, Inc.
Decision Date2020-06-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Abiomed 23 Fr Sheath is a medical device manufactured by Abiomed, Inc.. It received FDA 510(k) clearance on 2020-06-15 under approval number K201116. 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 Abiomed 23 Fr Sheath?
Abiomed 23 Fr Sheath is a medical device that received FDA 510(k) clearance on 2020-06-15. It is manufactured by Abiomed, Inc.. The 510(k) number is K201116.
When was Abiomed 23 Fr Sheath approved by the FDA?
Abiomed 23 Fr Sheath received FDA 510(k) clearance on 2020-06-15, under approval number K201116.
What company makes Abiomed 23 Fr Sheath?
Abiomed 23 Fr Sheath is manufactured by Abiomed, Inc..
What is the FDA product code for Abiomed 23 Fr Sheath?
The FDA product code for Abiomed 23 Fr 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.