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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 the device name listed in this FDA 510(k) record. The listed applicant is Sonorous NV, Inc.. It received FDA 510(k) clearance on 2026-04-21 under 510(k) 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. The listed applicant is Sonorous NV, Inc.. The 510(k) number is K254046.

When did BosCATH Support Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for BosCATH Support Catheter?

The FDA 510(k) record lists Sonorous NV, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BosCATH Support Catheter?

The FDA product code for BosCATH Support Catheter is QJP.

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Related Devices (Code: QJP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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