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510(k) Data Aggregation
K Number
K242419Device Name
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Manufacturer
Creagh Medical Ltd. dba Surmodics, Inc.
Date Cleared
2024-11-15
(92 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Creagh Medical Ltd. dba Surmodics, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Description
The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Anqioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtQ) and is intended for single use only.
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K Number
K211044Device Name
Sublime Radial Access 018 RX Dilatation Catheter
Manufacturer
Creagh Medical Ltd. (a wholly owned subsidiary of Surmodics,
Date Cleared
2021-06-16
(69 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Creagh Medical Ltd. (a wholly owned subsidiary of Surmodics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 018 Radial Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis in the iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Description
The 018 Radial Access Rx Dilatation Catheter is a co-axial rapid exchange (RX) catheter system with a semi compliant balloon at the distal end designed for use with a 0.018" guidewire. The guidewire will pass through a lumen from an RX access bond. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a single standard luer hub connector for connection of an inflation device. The inflation device is used to inflate and deflate the balloon with a contrast medium. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflated with inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The 018 Radial Access Rx Dilatation Catheter is provided sterile via ethylene oxide and is intended for single use only.
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K Number
K200700Device Name
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
Manufacturer
Creagh Medical Ltd.
Date Cleared
2020-05-14
(58 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Creagh Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sublime™ Radial Access 014 RX PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenoses in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Description
The 014 RX PTA Dilatation Catheter is a co-axial rapid exchange (RX) catheter system with a semi compliant balloon at the distal end designed for use with a 0.014" guidewire. The guidewire will pass through a lumen from an RX access bond. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a single standard luer hub connector for connection of an inflation device. The inflation device is used to inflate and deflate the balloon with a contrast medium. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflated with inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The 014 RX PTA Dilatation Catheter is to be provided sterile (via ethylene oxide, EtO) and is intended for single use only.
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