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Blowfish Transbronchial Micro-Infusion Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131401

by Mercator MedSystems, Inc.

Identifiers

510(k) Number
K131401 FDA 510(k)
FDA Product Code
EOQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.4680 FDA 510(k)
Regulation Number
874.4680 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device used to deliver therapeutic and diagnostic agents into selected and sub-selected regions of the airway tree. It contains a perpendicular stainless steel micro-needle port sheathed by a semi-rigid polymer actuator connected to a flexible shaft with a hub assembly at the proximal end.

This single-operator device is intended for airway, tracheal or bronchial delivery of agents indicated or labeled for such use. The Blowfish Transbronchial Micro-Infusion Catheter is supplied as a single-use device and is MRI conditional. It is authorized under FDA 510(k) clearance with product code EOQ and K-number K131401.

Frequently asked questions

What is the Blowfish Transbronchial Micro-Infusion Catheter used for?

The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device designed to deliver therapeutic and diagnostic agents into selected regions of the airway tree, including airway, tracheal or bronchial delivery of agents indicated for such use.

Is the Blowfish Transbronchial Micro-Infusion Catheter reusable or single-use?

The Blowfish Transbronchial Micro-Infusion Catheter is supplied as a single-use device, meaning it should be discarded after a single procedure to ensure safety and effectiveness.

What are the key features of the Blowfish Transbronchial Micro-Infusion Catheter?

This device contains a perpendicular stainless steel micro-needle port sheathed by a semi-rigid polymer actuator connected to a flexible shaft with a hub assembly at the proximal end. It is MRI conditional and designed for single-operator use.

What is the regulatory status of the Blowfish Transbronchial Micro-Infusion Catheter?

The Blowfish Transbronchial Micro-Infusion Catheter is authorized under FDA 510(k) clearance with product code EOQ and K-number K131401, classified as substantially equivalent to predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Blowfish® Transbronchial Micro-Infusion Device — Mercator MedSystems, AccessGUDID - DEVICE: Blowfish Micro-Infusion Catheter (M973BH201M1), BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER (K131401) — FDA 510(k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mercator MedSystems, Inc.

Sources (1)

  • FDA 510(k) K131401 24 fields · synced Sep 24, 2026