K-number	K231311
Device name	CPS Direct Universal slittable outer guide catheter (DS2C029)
Applicant	ABBOTT MEDICAL
Product code	DQY
Device class	Class II
Decision date	Jun 2, 2023
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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CPS Direct Universal slittable outer guide catheter (DS2C029)

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CPS Direct Universal slittable outer guide catheter (DS2C029)