FDA.reportPublic FDA data

510(k) K221294

Device
preCARDIA Occlusion System
Applicant
Abiomed, Inc.
510(k) number
K221294
Product code
MJN
Decision
Unknown (SESU)
Decision date
2023-06-30
Date received
2022-05-04
Regulation
870.4450
Classification name
Catheter, Intravascular Occluding, Temporary
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ken Ryder
Address
22 Cherry Hill Dr. Danvers MA US 01923 01923

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MJN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.2025-09-05
K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy Devices2025-06-24
K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.2022-09-19
K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLC2022-02-14
K212324RenovoCathRenovorx, Inc.2021-08-23
K210602AortaSTAT Occlusion DeviceRenalpro Medical, Inc.2021-07-09
K210358Neurescue deviceNeurescue Aps2021-05-21
K201652COBRA-OS KitFront Line Medical Technologies, Inc.2021-02-22
K203540Bridge Occlusion BalloonSpectranetics, Inc.2020-12-23
K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc.2020-06-03
K192786Gatekeeper Balloon CatheterArch Catheter, LLC2020-04-25
K193440ER-REBOA PLUS CatheterPrytime Medical Devices, Inc.2020-01-09
K191606RenovoCathRenovorx, Inc.2019-08-07
K183045Eclipse 2LBalt USA, LLC2019-04-30
K183679Occlusion Balloon CatheterQxmedical, LLC2019-04-24