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FDA 510(k)

Route 92 Medical Full Length 070 Access System

K-Number: K222743 · 2022-10-04

ApplicantRoute 92 Medical, Inc.
Decision Date2022-10-04
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Route 92 Medical Full Length 070 Access System is a medical device manufactured by Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2022-10-04 under approval number K222743. 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 070 Access System?

Route 92 Medical Full Length 070 Access System is a medical device that received FDA 510(k) clearance on 2022-10-04. It is manufactured by Route 92 Medical, Inc.. The 510(k) number is K222743.

When was Route 92 Medical Full Length 070 Access System approved by the FDA?

Route 92 Medical Full Length 070 Access System received FDA 510(k) clearance on 2022-10-04, under approval number K222743.

What company makes Route 92 Medical Full Length 070 Access System?

Route 92 Medical Full Length 070 Access System is manufactured by Route 92 Medical, Inc..

What is the FDA product code for Route 92 Medical Full Length 070 Access System?

The FDA product code for Route 92 Medical Full Length 070 Access System is QJP.

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Related PubMed Literature

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Other Devices by Route 92 Medical, Inc.

K182512Route 92 Medical Delivery Catheter K180201Route 92 Medical Access System K190431Route 92 Medical Delivery Catheter K203043Route 92 Medical 070 Access System K200121Route 92 Medical 088 Access System, 110 cm K191717Route 92 Medical Sheath System

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Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, Inc.

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.

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