K-number	K212026
Device name	Amplatzer Steerable Delivery Sheath
Applicant	ABBOTT MEDICAL
Product code	DQY
Device class	Class II
Decision date	Sep 27, 2021
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Amplatzer Steerable Delivery Sheath

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