Route 92 Medical Sheath System
K-Number: K191717 · 2020-01-13
ApplicantRoute 92 Medical, Inc.
Decision Date2020-01-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Route 92 Medical Sheath System is a medical device manufactured by Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2020-01-13 under approval number K191717. 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 Sheath System?
Route 92 Medical Sheath System is a medical device that received FDA 510(k) clearance on 2020-01-13. It is manufactured by Route 92 Medical, Inc.. The 510(k) number is K191717.
When was Route 92 Medical Sheath System approved by the FDA?
Route 92 Medical Sheath System received FDA 510(k) clearance on 2020-01-13, under approval number K191717.
What company makes Route 92 Medical Sheath System?
Route 92 Medical Sheath System is manufactured by Route 92 Medical, Inc..
What is the FDA product code for Route 92 Medical Sheath System?
The FDA product code for Route 92 Medical Sheath 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.