Abiomed 14Fr Low Profile Introducer Kit
K-Number: K241708 · 2024-08-06
ApplicantAbiomed, Inc.
Decision Date2024-08-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Abiomed 14Fr Low Profile Introducer Kit is a medical device manufactured by Abiomed, Inc.. It received FDA 510(k) clearance on 2024-08-06 under approval number K241708. 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 14Fr Low Profile Introducer Kit?
Abiomed 14Fr Low Profile Introducer Kit is a medical device that received FDA 510(k) clearance on 2024-08-06. It is manufactured by Abiomed, Inc.. The 510(k) number is K241708.
When was Abiomed 14Fr Low Profile Introducer Kit approved by the FDA?
Abiomed 14Fr Low Profile Introducer Kit received FDA 510(k) clearance on 2024-08-06, under approval number K241708.
What company makes Abiomed 14Fr Low Profile Introducer Kit?
Abiomed 14Fr Low Profile Introducer Kit is manufactured by Abiomed, Inc..
What is the FDA product code for Abiomed 14Fr Low Profile Introducer Kit?
The FDA product code for Abiomed 14Fr Low Profile Introducer Kit 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.