FDA 510(k)

Abiomed 14Fr Low Profile Introducer Set

K-Number: K222113 · 2022-10-13

Decision Date2022-10-13

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Abiomed 14Fr Low Profile Introducer Set is a medical device manufactured by Abiomed, Inc.. It received FDA 510(k) clearance on 2022-10-13 under approval number K222113. 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 Set?

Abiomed 14Fr Low Profile Introducer Set is a medical device that received FDA 510(k) clearance on 2022-10-13. It is manufactured by Abiomed, Inc.. The 510(k) number is K222113.

When was Abiomed 14Fr Low Profile Introducer Set approved by the FDA?

Abiomed 14Fr Low Profile Introducer Set received FDA 510(k) clearance on 2022-10-13, under approval number K222113.

What company makes Abiomed 14Fr Low Profile Introducer Set?

Abiomed 14Fr Low Profile Introducer Set is manufactured by Abiomed, Inc..

What is the FDA product code for Abiomed 14Fr Low Profile Introducer Set?

The FDA product code for Abiomed 14Fr Low Profile Introducer Set is DYB.

Other Devices by Abiomed, 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.