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FDA 510(k)

Route 92 Medical 088 Access System

K-Number: K201518 · 2020-08-14

ApplicantRoute 92 Medical
Decision Date2020-08-14
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Route 92 Medical 088 Access System is a medical device manufactured by Route 92 Medical. It received FDA 510(k) clearance on 2020-08-14 under approval number K201518. 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?

Route 92 Medical 088 Access System is a medical device that received FDA 510(k) clearance on 2020-08-14. It is manufactured by Route 92 Medical. The 510(k) number is K201518.

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

Route 92 Medical 088 Access System received FDA 510(k) clearance on 2020-08-14, under approval number K201518.

What company makes Route 92 Medical 088 Access System?

Route 92 Medical 088 Access System is manufactured by Route 92 Medical.

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

The FDA product code for Route 92 Medical 088 Access System is QJP.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026)

Related Devices (Code: 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.

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