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FDA 510(k)

BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER

K-Number: K131401 · 2013-07-02

ApplicantMercator Medsystems, Inc.
Decision Date2013-07-02
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mercator Medsystems, Inc.. It received FDA 510(k) clearance on 2013-07-02 under 510(k) number K131401. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER?

BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 2013-07-02. The listed applicant is Mercator Medsystems, Inc.. The 510(k) number is K131401.

When did BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER receive FDA 510(k) clearance?

BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER received FDA 510(k) clearance on 2013-07-02, under 510(k) number K131401.

Who is the listed applicant for BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER?

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

What is the FDA product code for BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER?

The FDA product code for BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER is EOQ.

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Other records listing Mercator Medsystems, Inc. as applicant

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.

K210339Bullfrog Micro-Infusion DeviceK161402Bullfrog Micro-Infusion DeviceK153501Bullfrog Micro-Infusion DeviceK062752MERCATOR MICROSYRINGE II INFUSION CATHETER

Related Devices (Code: EOQ)

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.

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/SK2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

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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