Bullfrog Micro-Infusion Device BF102P

GUDID M973BF102P18

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 tip 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.

MERCATOR MEDSYSTEMS, INC.

Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter

• Primary Device ID: M973BF102P18
• NIH Device Record Key: a6f00eae-c1b1-4366-adeb-fb7d511fc346
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bullfrog Micro-Infusion Device
• Version Model Number: MDL15-0616-145-HT
• Catalog Number: BF102P
• Company DUNS: 103706391
• Company Name: MERCATOR MEDSYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 510-614-4550
• Email: info@mercatormed.com
• Phone: 510-614-4550
• Email: info@mercatormed.com
• Phone: 510-614-4550
• Email: info@mercatormed.com
• Phone: 510-614-4550
• Email: info@mercatormed.com
• Phone: 510-614-4550
• Email: info@mercatormed.com
• Phone: 510-614-4550
• Email: info@mercatormed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M973BF102P18 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210339

FDA Product Code

• KRA: Catheter, Continuous Flush

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2021-10-24

On-Brand Devices [Bullfrog Micro-Infusion Device]

• M973BF102S1: The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
• M973BF102M1: The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
• M973BF102L1: The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
• M973BF101S1: The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
• M973BF101M1: The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
• M973BF101L1: The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
• M973BF102R1: The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
• M973BF102P18: The Mercator MedSystems® Bullfrog® Micro-Infusion Device is a wire-guided, endovascular cathet