K-number	K232343
Device name	AC3 Series IABP
Applicant	Arrow International, LLC
Product code	DSP
Device class	Class II
Decision date	Aug 30, 2023
Decision	Substantially Equivalent
Regulation	870.3535

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Source

View the full FDA submission: accessdata.fda.gov

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AC3 Series IABP

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AC3 Series IABP