Atlas FDA

UltraFlex IAB

FDA 510(k) clearance K190101 · decided 2019-06-28

Clearance details

K-number
K190101
Device name
UltraFlex IAB
Applicant
Arrow International, Inc.
Decision
Substantially Equivalent
Date received
2019-01-22
Decision date
2019-06-28
Days to decision
157 days
Clearance type
Traditional
Product code
DSP
Device class
2
Regulation number
870.3535
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Chelmsford, MA, US
Third-party review
No
Expedited review
No

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

RecordFirmDate
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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
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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