Atlas FDA

INTRA-AORTIC BALLOON (IAB)

FDA 510(k) clearance K040801 · decided 2004-05-06

Clearance details

K-number
K040801
Device name
INTRA-AORTIC BALLOON (IAB)
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
2004-03-29
Decision date
2004-05-06
Days to decision
38 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.

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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
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case (K163542)Datascope Corp.2017-01-31
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (K151254)Datascope Corp.2015-07-02

Recalls involving this device

RecordFirmDate
8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, recall (Z-1210-2009)Arrow International, Inc.2009-04-16
8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, recall (Z-1211-2009)Arrow International, Inc.2009-04-16
8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloo recall (Z-1212-2009)Arrow International, Inc.2009-04-16
8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The Intra-aortic balloo recall (Z-1213-2009)Arrow International, Inc.2009-04-16
7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic ba recall (Z-1214-2009)Arrow International, Inc.2009-04-16
7.5 Fr 40cc UltraFlex IAB, IAB-06840-U, Intra-aortic balloon catheter. The Intra-aortic ba recall (Z-1215-2009)Arrow International, Inc.2009-04-16
8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic b recall (Z-1216-2009)Arrow International, Inc.2009-04-16
8 Fr 40cc FIBEROPTIX IAB, IAB-05840-LWS, Intra-aortic balloon catheter. The Intra-aortic b recall (Z-1217-2009)Arrow International, Inc.2009-04-16
7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloo recall (Z-1218-2009)Arrow International, Inc.2009-04-16
8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloo recall (Z-1219-2009)Arrow International, Inc.2009-04-16
9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic ballo recall (Z-1220-2009)Arrow International, Inc.2009-04-16
ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic recall (Z-1221-2009)Arrow International, Inc.2009-04-16
ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic recall (Z-1222-2009)Arrow International, Inc.2009-04-16