K-number	K201112
Device name	AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
Applicant	Arrow International, Inc.
Product code	DSP
Device class	Class II
Decision date	May 27, 2020
Decision	Substantially Equivalent
Regulation	870.3535

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View the full FDA submission: accessdata.fda.gov

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AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP

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