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FDA 510(k)

8F Modified Sheath System

K-Number: K240529 · 2024-10-02

ApplicantRoute 92 Medical, Inc.
Decision Date2024-10-02
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

8F Modified Sheath System is a medical device manufactured by Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2024-10-02 under approval number K240529. 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 8F Modified Sheath System?

8F Modified Sheath System is a medical device that received FDA 510(k) clearance on 2024-10-02. It is manufactured by Route 92 Medical, Inc.. The 510(k) number is K240529.

When was 8F Modified Sheath System approved by the FDA?

8F Modified Sheath System received FDA 510(k) clearance on 2024-10-02, under approval number K240529.

What company makes 8F Modified Sheath System?

8F Modified Sheath System is manufactured by Route 92 Medical, Inc..

What is the FDA product code for 8F Modified Sheath System?

The FDA product code for 8F Modified Sheath System is QJP.

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Other Devices by Route 92 Medical, Inc.

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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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