K-number	K232437
Device name	Paragon 8F Balloon Guide Catheter
Applicant	Wallaby Medical
Product code	DQY
Device class	Class II
Decision date	Oct 13, 2023
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Paragon 8F Balloon Guide Catheter

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