Route 92 Medical Full Length 054 Access System
K-Number: K231583 · 2023-08-15
ApplicantRoute 92 Medical, Inc.
Decision Date2023-08-15
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Route 92 Medical Full Length 054 Access System is a medical device manufactured by Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2023-08-15 under approval number K231583. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Route 92 Medical Full Length 054 Access System?
Route 92 Medical Full Length 054 Access System is a medical device that received FDA 510(k) clearance on 2023-08-15. It is manufactured by Route 92 Medical, Inc.. The 510(k) number is K231583.
When was Route 92 Medical Full Length 054 Access System approved by the FDA?
Route 92 Medical Full Length 054 Access System received FDA 510(k) clearance on 2023-08-15, under approval number K231583.
What company makes Route 92 Medical Full Length 054 Access System?
Route 92 Medical Full Length 054 Access System is manufactured by Route 92 Medical, Inc..
What is the FDA product code for Route 92 Medical Full Length 054 Access System?
The FDA product code for Route 92 Medical Full Length 054 Access System is QJP.
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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.