FDA.reportPublic FDA data

Intra-aortic balloon pump

Definition
An electrically-powered device intended to inflate/deflate the balloon of an intra-aortic balloon catheter (not included) to assist cardiac function. The device monitors the patient’s electrocardiogram (ECG) and blood pressure to inflate/deflate the balloon in synchrony with the cardiac cycle, so that the balloon inflates after a cardiac contraction to increase perfusion of the coronary arteries and deflates before the next contraction to avoid obstructing aortic outflow. The device typically includes a main unit which incorporates a helium cylinder for balloon inflation/deflation, a screen, and controls.
GUDID devices
354
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00801902042422ARROWTELEFLEX INCORPORATEDIPN0002642015-10-16
00801902042439ARROWTELEFLEX INCORPORATEDIPN0002652015-10-16
00801902086761ARROWTELEFLEX INCORPORATEDIPN0002662015-10-16
00801902091154ARROWTELEFLEX INCORPORATEDIPN0010762018-03-10
10801902172065ARROWTELEFLEX INCORPORATEDIPN9172852021-09-27
10801902172072ARROWTELEFLEX INCORPORATEDIPN9172862021-09-27
10801902172089ARROWTELEFLEX INCORPORATEDIPN9172872021-09-27
10801902172096ARROWTELEFLEX INCORPORATEDIPN9172882021-09-27
10801902179354ARROWTELEFLEX INCORPORATEDIPN9190072021-09-17
10801902182835ARROWTELEFLEX INCORPORATEDIPN9191872021-09-13
10801902182842ARROWTELEFLEX INCORPORATEDIPN9191882021-09-22
10801902182859ARROWTELEFLEX INCORPORATEDIPN9191892021-09-07
10801902182866ARROWTELEFLEX INCORPORATEDIPN9191902021-09-07
10801902182873ARROWTELEFLEX INCORPORATEDIPN9191912021-09-07
10801902214451ARROWTELEFLEX INCORPORATEDIPN9276082023-02-03
10801902219609ARROWTELEFLEX INCORPORATEDIPN9292832025-04-30
30801902093777ARROWTELEFLEX INCORPORATEDIPN0010792016-09-16
30801902093838ARROWTELEFLEX INCORPORATEDIPN0010922016-09-16
30801902093852ARROWTELEFLEX INCORPORATEDIPN0010862016-09-16
30801902093937ARROWTELEFLEX INCORPORATEDIPN0010942016-09-16
30801902093999ARROWTELEFLEX INCORPORATEDIPN0011072016-09-16
30801902094019ARROWTELEFLEX INCORPORATEDIPN0011012016-09-16
10801902143140ARROWTELEFLEX INCORPORATEDIPN0010642018-10-29
10801902143157ARROWTELEFLEX INCORPORATEDIPN0386452018-10-26
10801902223729ARROWTELEFLEX INCORPORATEDIPN9312502025-10-02
10801902223859ARROWTELEFLEX INCORPORATEDIPN9312792025-10-02
20801902219606ARROWTELEFLEX INCORPORATEDIPN9292832025-04-30
10607567113432CARDIOSAVE HYBRID, 3.1 EDITIONDatascope Corp.0998-00-0800-652024-09-09
10607567113449CARDIOSAVE RESCUE, 3.1 EDITIONDatascope Corp.0998-00-0800-852024-09-09
10607567114187"CARDIOSAVE HYBRID - TYPE ""N"" PLUG"Datascope Corp.0998-00-0800-362024-09-09
10801902217254ARROWTELEFLEX INCORPORATEDIPN9288402024-02-27
10801902217247ARROWTELEFLEX INCORPORATEDIPN9288392024-02-12
00801902172679ARROWTELEFLEX INCORPORATEDIPN9158792023-02-07
00801902214393ARROWTELEFLEX INCORPORATEDIPN9276022023-02-07
00801902214416ARROWTELEFLEX INCORPORATEDIPN9276042023-02-07
00801902214515ARROWTELEFLEX INCORPORATEDIPN9276142023-02-07
10801902141436ARROWTELEFLEX INCORPORATEDIPN9274302023-02-07
10801902141450ARROWTELEFLEX INCORPORATEDIPN9274322023-02-07
10801902141474ARROWTELEFLEX INCORPORATEDIPN9274342023-02-07
10801902141498ARROWTELEFLEX INCORPORATEDIPN9274362023-02-07
10801902141504ARROWTELEFLEX INCORPORATEDIPN9274372023-02-07
10801902214376ARROWTELEFLEX INCORPORATEDIPN9276002023-02-07
10801902214383ARROWTELEFLEX INCORPORATEDIPN9276012023-02-07
10801902214406ARROWTELEFLEX INCORPORATEDIPN9276032023-02-07
10801902214482ARROWTELEFLEX INCORPORATEDIPN9276112023-02-07
10801902214499ARROWTELEFLEX INCORPORATEDIPN9276122023-02-07
10801902214505ARROWTELEFLEX INCORPORATEDIPN9276132023-02-07
00801902214461ARROWTELEFLEX INCORPORATEDIPN9276092023-02-03
10801902214352ARROWTELEFLEX INCORPORATEDIPN9275982023-02-03
10801902214369ARROWTELEFLEX INCORPORATEDIPN9275992023-02-03
10801902214420ARROWTELEFLEX INCORPORATEDIPN9276052023-02-03
10801902214437ARROWTELEFLEX INCORPORATEDIPN9276062023-02-03
10801902214444ARROWTELEFLEX INCORPORATEDIPN9276072023-02-03
10801902214475ARROWTELEFLEX INCORPORATEDIPN9276102023-02-03
10801902214529ARROWTELEFLEX INCORPORATEDIPN9276152023-02-03
10801902214536ARROWTELEFLEX INCORPORATEDIPN9276162023-02-03
10801902214543ARROWTELEFLEX INCORPORATEDIPN9276172023-02-03
10801902214550ARROWTELEFLEX INCORPORATEDIPN9276182023-02-03
10801902214567ARROWTELEFLEX INCORPORATEDIPN9276192023-02-03
10801902214574ARROWTELEFLEX INCORPORATEDIPN9276202023-02-03
10801902214581ARROWTELEFLEX INCORPORATEDIPN9276212023-02-03
20801902214458ARROWTELEFLEX INCORPORATEDIPN9276082023-02-03
20801902172062ARROWTELEFLEX INCORPORATEDIPN9172852021-09-27
20801902172079ARROWTELEFLEX INCORPORATEDIPN9172862021-09-27
20801902172086ARROWTELEFLEX INCORPORATEDIPN9172872021-09-27
20801902172093ARROWTELEFLEX INCORPORATEDIPN9172882021-09-27
10801902201949ARROWTELEFLEX INCORPORATEDIPN9158612021-09-24
10801902205237ARROWTELEFLEX INCORPORATEDIPN9158712021-09-24
20801902182849ARROWTELEFLEX INCORPORATEDIPN9191882021-09-22
20801902179351ARROWTELEFLEX INCORPORATEDIPN9190072021-09-17
00801902172297ARROWTELEFLEX INCORPORATEDIPN9158442021-09-16
00801902172341ARROWTELEFLEX INCORPORATEDIPN9158492021-09-16
00801902172372ARROWTELEFLEX INCORPORATEDIPN9158522021-09-16
00801902172396ARROWTELEFLEX INCORPORATEDIPN9158542021-09-16
00801902172402ARROWTELEFLEX INCORPORATEDIPN9158552021-09-16
00801902172457ARROWTELEFLEX INCORPORATEDIPN9158582021-09-16
00801902172495ARROWTELEFLEX INCORPORATEDIPN9158632021-09-16
00801902172556ARROWTELEFLEX INCORPORATEDIPN9158652021-09-16
00801902172600ARROWTELEFLEX INCORPORATEDIPN9158702021-09-16
00801902172617ARROWTELEFLEX INCORPORATEDIPN9158722021-09-16