Atlas FDA

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

FDA 510(k) clearance K000729 · decided 2000-05-19

Clearance details

K-number
K000729
Device name
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
2000-03-06
Decision date
2000-05-19
Days to decision
74 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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Recalls involving this device

RecordFirmDate
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; recall (Z-1879-2024)ARROW INTERNATIONAL Inc.2024-06-03
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840- recall (Z-1880-2024)ARROW INTERNATIONAL Inc.2024-06-03
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow IAB is utilized for intra aorti recall (Z-1056-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow IAB is utilized for intra aorti recall (Z-1058-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow IAB is utilized for intra a recall (Z-1059-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra a recall (Z-1060-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra a recall (Z-1062-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product recall (Z-1064-2013)Arrow International Inc2013-04-06
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product recall (Z-1065-2013)Arrow International Inc2013-04-06
Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U recall (Z-0790-2011)Arrow International, Inc., Division of Teleflex Medical Inc.2010-12-23
Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U recall (Z-0791-2011)Arrow International, Inc., Division of Teleflex Medical Inc.2010-12-23
FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS recall (Z-0792-2011)Arrow International, Inc., Division of Teleflex Medical Inc.2010-12-23
FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS recall (Z-0793-2011)Arrow International, Inc., Division of Teleflex Medical Inc.2010-12-23
Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Cathete recall (Z-0969-2011)Arrow International, Inc., Division of Teleflex Medical Inc.2010-12-23
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