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BosCATH Support Catheter

by Sonorous NV, Inc.

510(k) K254046

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK254046 Date21 Apr 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QJP
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BosCATH Support Catheter is a percutaneous neurovascular catheter designed for use in cerebral venous and arterial procedures. It is classified as a Class 2 device under the FDA’s product code QJP, intended for neurovascular applications. The catheter provides structural support during interventions, facilitating precise delivery of therapeutic devices or contrast agents in complex anatomies.

This device is supplied as a single-use, sterile catheter and is regulated under FDA 510(k) clearance (K254046) via the Traditional pathway. It is intended for use in neurovascular procedures, with no explicit MRI safety classification noted. The catheter is available in multiple reference codes (e.g., 1721676, 3012543881) and is authorized for use in the United States under the regulation number 870.1250. Storage and handling follow standard sterile medical device protocols.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BosCATH Support Catheter used for?

    The BosCATH Support Catheter is designed specifically for neurovascular procedures, offering structural support during interventions. This helps clinicians achieve precise delivery of therapeutic devices or contrast agents in cerebral venous and arterial anatomies, where stability and accuracy are critical.

  • Is the BosCATH Support Catheter single-use or reusable?

    The BosCATH Support Catheter is supplied as a single-use device. This ensures sterility and reduces the risk of contamination or cross-infection between patients, adhering to standard sterile medical device protocols.

  • What reference codes or models are available for the BosCATH Support Catheter?

    The BosCATH Support Catheter is available in multiple reference codes, including 1721676, 3012543881, and several others. These variations may correspond to different sizes or configurations to suit specific neurovascular procedural needs.

  • How should the BosCATH Support Catheter be stored?

    The BosCATH Support Catheter should be stored following standard sterile medical device protocols. This typically involves keeping it in its original, unopened packaging in a clean, dry environment, protected from direct sunlight and extreme temperatures, to maintain sterility and functionality.

  • Is there any specific MRI safety classification for the BosCATH Support Catheter?

    The provided information does not explicitly state an MRI safety classification for the BosCATH Support Catheter. Clinicians should verify compatibility with their specific MRI systems before use, as MRI safety can vary depending on the materials and construction of the device.