Atlas FDA

AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES

FDA 510(k) clearance K060309 · decided 2006-04-06

Clearance details

K-number
K060309
Device name
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
2006-02-07
Decision date
2006-04-06
Days to decision
58 days
Clearance type
Special
Product code
DSP
Device class
2
Regulation number
870.3535
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Everett, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
AC3™ Range™ Intra-Aortic Balloon Pump (K250542)Arrow International, LLC2025-03-26
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UltraFlex IAB (K190101)Arrow International, Inc.2019-06-28
Fiberoptix IAB (K190117)Arrow International, Inc.2019-06-13
CARDIOSAVE Intra-Aortic Balloon Pump (K181122)Datascope Corp.2018-05-31
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (K172305)Datascope Corp.2017-10-12
AC3 Series IABP System (K162820)Arrow International, Inc.2017-03-31
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Recalls involving this device

RecordFirmDate
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardia recall (Z-0426-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN00 recall (Z-0427-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac recall (Z-0428-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac recall (Z-0429-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000 recall (Z-0430-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), ca recall (Z-0431-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IP recall (Z-0432-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305) recall (Z-0444-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306) recall (Z-0445-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308) recall (Z-0446-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN0 recall (Z-0447-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN0 recall (Z-0448-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN recall (Z-0449-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN0 recall (Z-0450-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN0 recall (Z-0451-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN0 recall (Z-0452-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN recall (Z-0453-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN recall (Z-0454-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN0 recall (Z-0455-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN0 recall (Z-0456-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 recall (Z-2408-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E recall (Z-2409-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 recall (Z-2410-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E recall (Z-2411-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I recall (Z-2412-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J recall (Z-2413-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL recall (Z-2414-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535 recall (Z-2415-2020)Arrow International Inc2020-06-26
AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and recall (Z-0550-2008)Arrow International Inc2008-01-25