K-number	K191078
Device name	BAROnova Access Sheath Kit
Applicant	Baronova, Inc.
Product code	QGG
Device class	Class II
Decision date	Jul 22, 2019
Decision	Unknown
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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BAROnova Access Sheath Kit

Everything you need for a 510(k) submission. Nothing you don't.