FDA.reportPublic FDA data

Blowfish Micro-Infusion Catheter

Primary DI
M973BL06161
Brand
Blowfish Micro-Infusion Catheter
Company
MERCATOR MEDSYSTEMS, INC.
Model
MDL09-0616-145-HT
Catalog number
BH201M
Device description
The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
Published
2020-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M973BL06161PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
510-614-4550info@mercatormed.com

Regulatory Flags#

DUNS number
103706391
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M973BF103P1LEAPFROG Micro-Infusion DeviceMDL18-0616-120-HTBF103P2023-04-17
M973BF102P18Bullfrog Micro-Infusion DeviceMDL15-0616-145-HTBF102P2021-10-24
M973BF102R1Bullfrog Micro-Infusion DeviceMDL09-2040-145-HT-RBF102R2020-04-08
M973BF101L1Bullfrog Micro-Infusion DeviceMDL15-4080-145BF101L2017-01-20
M973BF101M1Bullfrog Micro-Infusion DeviceMDL12-3060-145BF101M2017-01-20
M973BF101S1Bullfrog Micro-Infusion DeviceMDL09-2040-145-34BF101S2017-01-20
M973BF102L1Bullfrog Micro-Infusion DeviceMDL15-4080-145-HTBF102L2018-02-23
M973BF102M1Bullfrog Micro-Infusion DeviceMDL12-3060-145-HTBF102M2018-02-23
M973BF102S1Bullfrog Micro-Infusion DeviceMDL09-2040-145-HTBF102S2018-02-23
M973BH201M1Blowfish Micro-Infusion CatheterMDL09-0616-145-34BH201M2017-01-20

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