Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
K-Number: K243601 · 2025-05-19
ApplicantRoute 92 Medical, Inc.
Decision Date2025-05-19
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is a medical device manufactured by Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2025-05-19 under approval number K243601. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set?
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2025-05-19. It is manufactured by Route 92 Medical, Inc.. The 510(k) number is K243601.
When was Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set approved by the FDA?
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set received FDA 510(k) clearance on 2025-05-19, under approval number K243601.
What company makes Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set?
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is manufactured by Route 92 Medical, Inc..
What is the FDA product code for Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set?
The FDA product code for Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is NRY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.