ClearanceBrief
Panels › Cardiovascular › Product code DSP · Class 2

System, Balloon, Intra-Aortic And Control

Regulation 870.3535

0510(k)s in 12 months (162 all time)
7recalls in 12 months (194 all time)
181recalls that name a 510(k)
Get daily alerts for DSPSample briefCSV

Top companies in DSP

Company510(k)sRecalls
Datascope Corp.64101
Arrow International, Inc.763
Kontron Instruments, Inc.170
Arrow Intl., Inc.150
Arrow International, Inc., Division of Teleflex Medical Inc.014
Boston Scientific Corp140
Maquet Datascope Corp - Cardiac Assist Division014
Aries Medical, Inc.80
Smec, Inc.70
Belmont Instrument Corp.50
DateFirm and productCodeLinked 510(k)
Mar 6, 2023Datascope Corp.
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Open, Classified		 DSPK181122
Mar 6, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998
Open, Classified		 DSPK181122
Jan 19, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
Open, Classified		 DSPK181122
Jan 19, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52
Open, Classified		 DSPK181122
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
Open, Classified		 DSPK201112
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
Open, Classified		 DSPK060309
Dec 15, 2022ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Open, Classified		 DSPK060309
Sep 8, 2022Datascope Corporation
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Open, Classified		 DSPK133074
Sep 8, 2022Datascope Corporation
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Open, Classified		 DSPK133074
Sep 8, 2022Datascope Corporation
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Open, Classified		 DSPK133074
Dec 30, 2021Datascope Corp.
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
Open, Classified		 DSPK112372
K151254 +1
Dec 30, 2021Datascope Corp.
Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-
Open, Classified		 DSPK112372
K151254 +1
Oct 20, 2021Datascope Corp.
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-
Open, Classified		 DSPK112372
K151254 +2
Oct 7, 2021Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified		 DSPK181122
Oct 7, 2021Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0
Open, Classified		 DSPK112372
K151254 +1
Sep 8, 2021Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified		 DSPK181122
Sep 8, 2021Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0
Open, Classified		 DSPK112372
K151254 +1
Apr 28, 2021Datascope Corp.
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998
Open, Classified		 DSPK112372
K151254 +1
Apr 28, 2021Datascope Corp.
Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998
Open, Classified		 DSPK112372
K151254 +1
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surg
Open, Classified		 DSPNone listed
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surg
Open, Classified		 DSPNone listed
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surg
Open, Classified		 DSPNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.