K-number	K190431
Device name	Route 92 Medical Delivery Catheter
Applicant	Route 92 Medical, Inc.
Product code	DQY
Device class	Class II
Decision date	Mar 21, 2019
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Route 92 Medical Delivery Catheter

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