ClearanceBrief
510(k) K000729 ยท DSP System, Balloon, Intra-Aortic And Control

ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL

ApplicantArrow Intl., Inc., Everett MA, US
DecisionSubstantially Equivalent, May 19, 2000
ReceivedMar 6, 2000
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K000729

DateFirm and productCodeLinked 510(k)
Jun 3, 2024ARROW INTERNATIONAL Inc.
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Open, Classified
DSPNone listed
Jun 3, 2024ARROW INTERNATIONAL Inc.
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Open, Classified
DSPNone listed
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, du
Terminated
DSPNone listed
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, du
Terminated
DSPNone listed
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation
Terminated
DSPNone listed
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation
Terminated
DSPNone listed
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation
Terminated
DSPNone listed
Apr 6, 2013Arrow International Inc
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Terminated
DSPNone listed
Apr 6, 2013Arrow International Inc
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Terminated
DSPNone listed
Dec 23, 2010Arrow International, Inc., Division of Teleflex Medical Inc.
Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U
Terminated
DSPNone listed
Dec 23, 2010Arrow International, Inc., Division of Teleflex Medical Inc.
Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
Terminated
DSPNone listed
Dec 23, 2010Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
Terminated
DSPNone listed
Dec 23, 2010Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS
Terminated
DSPNone listed
Dec 23, 2010Arrow International, Inc., Division of Teleflex Medical Inc.
Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy,
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy,
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during dia
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
7.5 Fr 40cc UltraFlex IAB, IAB-06840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during dias
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during dia
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
8 Fr 40cc FIBEROPTIX IAB, IAB-05840-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during dia
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastol
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during
Terminated
DSPNone listed
Apr 16, 2009Arrow International, Inc.
ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during
Terminated
DSPNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.