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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: DSP Applicant: ARROW INTL., INC. Decision Date To: 04/19/2024
 
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8 fr. -30cc narrowflex sheathless intra-aortic balloon catheter, product number iab-04830s ARROW INTL., INC. K963865 09/16/1997
8 fr.-30cc narrowflex intra-aortic balloon catheter, ARROW INTL., INC. K963920 06/17/1997
8 fr.-40cc arrow flex intra-aortic balloon catheter with blue flex tip, product number iab-04840(used with a 9fr.sheath) ARROW INTL., INC. K960713 05/15/1996
8fr. narrowflex universal intra-aortic balloon catheter ARROW INTL., INC. K993966 02/18/2000
9.5 fr.- flexi-cath intra-aortic and control system ARROW INTL., INC. K963104 02/04/1997
acat 1 (arrow cardiac assist technology 1) ARROW INTL., INC. K965209 01/23/1998
arrow acat 2 intra-aortic balloon pump ARROW INTL., INC. K002256 05/03/2001
arrow intra-aortic balloon (iab) catheter with a fiber optic sensor and a measurement system, models iab-05830-f,iab5840 ARROW INTL., INC. K021462 06/06/2002
arrow kink resistant flexi-cath intra-aortic balloon ARROW INTL., INC. K945230 05/09/1995
arrow rediguard, 9fr. 50cc, intra-aortic balloon vatheter, iab-r950-u ARROW INTL., INC. K010330 03/02/2001
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