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FDA 510(k)

Route 92 Medical 088 Access System, 110 cm

K-Number: K200121 · 2020-04-18

ApplicantRoute 92 Medical, Inc.
Decision Date2020-04-18
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Route 92 Medical 088 Access System, 110 cm is a medical device manufactured by Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2020-04-18 under approval number K200121. 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 088 Access System, 110 cm?

Route 92 Medical 088 Access System, 110 cm is a medical device that received FDA 510(k) clearance on 2020-04-18. It is manufactured by Route 92 Medical, Inc.. The 510(k) number is K200121.

When was Route 92 Medical 088 Access System, 110 cm approved by the FDA?

Route 92 Medical 088 Access System, 110 cm received FDA 510(k) clearance on 2020-04-18, under approval number K200121.

What company makes Route 92 Medical 088 Access System, 110 cm?

Route 92 Medical 088 Access System, 110 cm is manufactured by Route 92 Medical, Inc..

What is the FDA product code for Route 92 Medical 088 Access System, 110 cm?

The FDA product code for Route 92 Medical 088 Access System, 110 cm 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 K191717Route 92 Medical Sheath System K210635Route 92 Medical Full Length 088 Access 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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