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FDA 510(k)

Route 92 Medical Delivery Catheter

K-Number: K190431 · 2019-03-21

ApplicantRoute 92 Medical, Inc.
Decision Date2019-03-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Route 92 Medical Delivery Catheter is a medical device manufactured by Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2019-03-21 under approval number K190431. 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 Delivery Catheter?

Route 92 Medical Delivery Catheter is a medical device that received FDA 510(k) clearance on 2019-03-21. It is manufactured by Route 92 Medical, Inc.. The 510(k) number is K190431.

When was Route 92 Medical Delivery Catheter approved by the FDA?

Route 92 Medical Delivery Catheter received FDA 510(k) clearance on 2019-03-21, under approval number K190431.

What company makes Route 92 Medical Delivery Catheter?

Route 92 Medical Delivery Catheter is manufactured by Route 92 Medical, Inc..

What is the FDA product code for Route 92 Medical Delivery Catheter?

The FDA product code for Route 92 Medical Delivery Catheter is DQY.

Related Clinical Trials

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Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025)

Other Devices by Route 92 Medical, Inc.

K182512Route 92 Medical Delivery Catheter K180201Route 92 Medical Access System K203043Route 92 Medical 070 Access System K200121Route 92 Medical 088 Access System, 110 cm K191717Route 92 Medical Sheath System K210635Route 92 Medical Full Length 088 Access System

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Related Devices (Code: 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.

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