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510(k) Data Aggregation
K Number
K243577Device Name
Radical the Dude 8F Guide Catheter
Manufacturer
Maduro Medical, Inc.
Date Cleared
2025-01-14
(56 days)
Product Code
QJP, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Maduro Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radical the Dude 8F Guide Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.
Device Description
The Radical the Dude 8F Guide Catheter (Dude 8F Catheter) is an 8 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 8F Catheter has a usable length between 80 cm and 110 cm, and an outer diameter (OD) size designation of 8 Fr. The Dude 8F Catheter has variable stiffness along its length, incorporating hybrid ribbon technologies to maintain stability and vary stiffness along the device length. The distal portion of the Dude 8F Catheter has a hydrophilic coating. The Dude 8F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.
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K Number
K231393Device Name
Radical the Dude 7F Guide Catheter
Manufacturer
Maduro Medical, Inc.
Date Cleared
2023-11-30
(202 days)
Product Code
QJP, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Maduro Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radical the Dude 7F Guide Catheter is indicated for the intravascular catheters into the peripheral, coronary, and neuro vasculature.
Device Description
The Radical the Dude 7F Guide Catheter (Dude 7F Catheter) is a 7 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 7F Catheter has a usable length between 95 cm and 115 cm, and an outer diameter (OD) size designation of 7 Fr. The Dude 7F Catheter has variable stiffness along its length, incorporating hybrid ribbon technologies to maintain stability and vary stiffness along the device length. The distal portion of the Dude 7F Catheter has a hydrophilic coating. The Dude 7F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.
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