Name: Predicase
Price: 199 USD

K-number	K223530
Device name	Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Applicant	Route 92 Medical, Inc.
Product code	NRY
Device class	Class II
Decision date	Apr 11, 2023
Decision	Substantially Equivalent
Regulation	870.1250

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

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