Bullfrog Micro-Infusion Device - The Mercator MedSystems Bullfrog Micro-Infusion - MERCATOR MEDSYSTEMS, INC.

Duns Number:103706391

Device Description: The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular cath The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a semi-rigid polymer actuator. The device is designed to be advanced to target vasculature and hydraulically actuated to move the microneedle through the external elastic lamina to deliver substances to adventitial and perivascular tissues. A compliant stabilizing balloon inflates with the actuator to provide a force opposite the needle tip for proper seating of the needle. The needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.

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More Product Details

Catalog Number

BF101L

Brand Name

Bullfrog Micro-Infusion Device

Version/Model Number

MDL15-4080-145

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 03, 2018

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KRA

Product Code Name

Catheter, Continuous Flush

Device Record Status

Public Device Record Key

f412b314-3ab8-44f8-a648-5a3ca13730dc

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

January 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERCATOR MEDSYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10