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FDA 510(k)

BosCATH Support Catheter

K-Number: K254046 · 2026-04-21

ApplicantSonorous NV, Inc.
Decision Date2026-04-21
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BosCATH Support Catheter is a medical device manufactured by Sonorous NV, Inc.. It received FDA 510(k) clearance on 2026-04-21 under approval number K254046. 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 BosCATH Support Catheter?

BosCATH Support Catheter is a medical device that received FDA 510(k) clearance on 2026-04-21. It is manufactured by Sonorous NV, Inc.. The 510(k) number is K254046.

When was BosCATH Support Catheter approved by the FDA?

BosCATH Support Catheter received FDA 510(k) clearance on 2026-04-21, under approval number K254046.

What company makes BosCATH Support Catheter?

BosCATH Support Catheter is manufactured by Sonorous NV, Inc..

What is the FDA product code for BosCATH Support Catheter?

The FDA product code for BosCATH Support Catheter is QJP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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