Atlas FDA

ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U

FDA 510(k) clearance K010330 · decided 2001-03-02

Clearance details

K-number
K010330
Device name
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
2001-02-02
Decision date
2001-03-02
Days to decision
28 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
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