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510(k) Data Aggregation
K Number
K123818Device Name
URSA ANGIOGRAPHIC CATHETER
Manufacturer
Date Cleared
2013-03-04
(82 days)
Product Code
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
CURATIVE MEDICAL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ursa™ angiographic catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature. The device is for single use only. This device is not intended for use in the neurovasculature.
Device Description
The Ursa™ angiographic catheters are sterile, single use, disposable devices designed to deliver radiopaque contrast media to selected sites in the vascular system. It is available in 39different curve shapes and three sizes of 4, 5 and 6F. This Special 510(k) adds sixteen (16) new shapes to the current commercially available selection of catheters. Each device consists of a catheter with luer connector: strain relief, catheter shaft, catheter soft extension and soft distal tip. The distal end of the catheter is formed into a variety of shapes required to access a variety of vascular anatomies. All versions of the catheters are designed to accept a maximum guidewire diameter of 0.038" and have a strain relief at the hub to shaft junction. Sideholes may be incorporated into the shaft to facilitate injection of radiopaque contrast media.
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K Number
K090427Device Name
URSA ANGIOGRAPHIC CATHETER
Manufacturer
Date Cleared
2010-01-29
(344 days)
Product Code
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
CURATIVE MEDICAL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ursa™ angiographic catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature. The device is for single use only. This device is not intended for use in the neurovasculature.
Device Description
The Ursa™ angiographic catheters are sterile, single use, disposable devices designed to deliver radiopaque contrast media to selected sites in the vascular system. It is available in 39 different curve shapes and three sizes of 4. 5 and 6F. Each device consists of a catheter with luer connector; strain relief, catheter shaft, catheter soft extension and soft distal tip. The distal end of the catheter is formed into a variety of shapes required to access a variety of vascular anatomies. All versions of the catheters are designed to accept a maximum guidewire diameter of 0.038" and have a strain relief at the hub to shaft junction. Sideholes may be incorporated into the shaft to facilitate injection of radiopaque contrast media.
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Ask a specific question about this device
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