Abiomed, Inc. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
14Fr Low Profile Introducer Kit510(k)Oct 8, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Oct 8, 2025
Abiomed 14Fr Low Profile Introducer Kit510(k)Aug 6, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 6, 2024
preCARDIA Occlusion System510(k)Jun 30, 2023Cardiovascular	Cardiovascular	510(k)Unknown (Traditional)	Jun 30, 2023
OXY-1 System510(k)Feb 23, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 23, 2023
Abiomed 14Fr Low Profile Introducer Set510(k)Oct 13, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 13, 2022