Route 92 Medical Access System
K-Number: K180201 · 2018-05-23
ApplicantRoute 92 Medical, Inc.
Decision Date2018-05-23
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Route 92 Medical Access System is a medical device manufactured by Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2018-05-23 under approval number K180201. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Route 92 Medical Access System?
Route 92 Medical Access System is a medical device that received FDA 510(k) clearance on 2018-05-23. It is manufactured by Route 92 Medical, Inc.. The 510(k) number is K180201.
When was Route 92 Medical Access System approved by the FDA?
Route 92 Medical Access System received FDA 510(k) clearance on 2018-05-23, under approval number K180201.
What company makes Route 92 Medical Access System?
Route 92 Medical Access System is manufactured by Route 92 Medical, Inc..
What is the FDA product code for Route 92 Medical Access System?
The FDA product code for Route 92 Medical Access System is DQY.
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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.