FDA.reportPublic FDA data

510(k) K250542

Device
AC3? Range? Intra-Aortic Balloon Pump
Applicant
Arrow International, LLC
510(k) number
K250542
Product code
DSP
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-26
Date received
2025-02-24
Regulation
870.3535
Classification name
System, Balloon, Intra-Aortic And Control
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Apurva Gokhale
Address
(Subsidiary Of Teleflex Incorporated) 3015 Carrington Mill Blvd. Morrisville NC US 27560 27560

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESDatascope Corp.2013-12-12
K122628SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIESDatascope Corp., Cardiac Assist Division2012-09-06
K120868MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETERDatascope Corp., Cardiac Assist Division2012-04-20
K112372CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPCardiac Assist, Maquet Cardiovascular, LLC2011-09-15