K-number	K201116
Device name	Abiomed 23 Fr Sheath
Applicant	Abiomed, Inc.
Product code	DYB
Device class	Class II
Decision date	Jun 15, 2020
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Abiomed 23 Fr Sheath

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