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U.S. Department of Health and Human Services

510(k) Premarket Notification
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11 to 15 of 15 Results
ProductCode: DSP Applicant: ARROW INTL., INC. Decision Date To: 04/23/2024
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510(K)
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8 fr.-30cc narrowflex intra-aortic balloon catheter, ARROW INTL., INC. K963920 06/17/1997
9.5 fr.- flexi-cath intra-aortic and control system ARROW INTL., INC. K963104 02/04/1997
arrow sheathless intra-aortic balloon catheter ARROW INTL., INC. K961358 07/02/1996
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
arrow kink resistant flexi-cath intra-aortic balloon ARROW INTL., INC. K945230 05/09/1995
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