FDA.reportPublic FDA data

LEAPFROG Micro-Infusion Device

Primary DI
M973BF103P1
Brand
LEAPFROG Micro-Infusion Device
Company
MERCATOR MEDSYSTEMS, INC.
Model
MDL18-0616-120-HT
Catalog number
BF103P
Device description
The Mercator MedSystems® LeapFrog 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 peripheral 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.
Published
2023-04-17
Public version status
New
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
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210339000Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.2021-08-02KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M973BF103P1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. 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
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
M973BL06161Blowfish Micro-Infusion CatheterMDL09-0616-145-HTBH201M2020-04-08
M973BH201M1Blowfish Micro-Infusion CatheterMDL09-0616-145-34BH201M2017-01-20

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B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00810123710140ClotTriever CatheterInari Medical, Inc.KRA2024-04-17
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00850291007376Artix AXInari Medical, Inc.KRA2023-04-24
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00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22