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Found 3 results
510(k) Data Aggregation
K Number
K242644Device Name
SENDERO MAX Delivery Catheter
Manufacturer
Okami Medical, Inc.
Date Cleared
2024-12-20
(108 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Okami Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SENDERO MAX Delivery Catheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.
Device Description
The SENDERO MAX Delivery Catheter is a single lumen, variable stiffness catheter with a radiopaque marker on the shaped distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guide wire, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.
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K Number
K240384Device Name
SENDERO Microcatheter
Manufacturer
Okami Medical, Inc.
Date Cleared
2024-03-08
(29 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Okami Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.
Device Description
The SENDERO Microcatheter is a single lumen, variable stiffness catheter with a radiopaque marker on the distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guidewire, guide catheter, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.
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K Number
K231600Device Name
SENDERO Microcatheter
Manufacturer
Okami Medical, Inc.
Date Cleared
2023-11-17
(169 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Okami Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic agents.
Device Description
The SENDERO Microcatheter is a single lumen, variable stiffness catheter with a radiopaque marker on the distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guidewire, guide catheter, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.
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