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510(k) Data Aggregation
K Number
K132197Device Name
CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER
Manufacturer
PENDRACARE INTERNATIONAL, B.V.
Date Cleared
2013-08-12
(27 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
PENDRACARE INTERNATIONAL, B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Convey Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
Device Description
The guiding catheter is a flexible plastic tube featuring a luer hub, a strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip exist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and / or therapeutic (interventional) devices within the vascular system. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multipurpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "inline" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded.
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K Number
K120585Device Name
CONVEY GUIDING CATHETER
Manufacturer
PENDRACARE INTERNATIONAL, B.V.
Date Cleared
2012-08-08
(163 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
PENDRACARE INTERNATIONAL, B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Device Description
The guiding catheter is a flexible plastic tube featuring a luer hub, a strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip exist of an inner liner (basecoat) and a outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and therapeutic devices within the vascular system. After the catheter is inserted through the skin using a dilator, a sheath (introducer) and a guide wire it is brought into position. Subsequently, a guidewire is advanced through its lumen and tracked over by a diagnostic device (angiographic catheter, IVUS-catheter) and/or a therapeutic device (e.g., balloon dilatation catheter, stent and delivery system, embolization device) to the intended location. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multi-purpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "in-line" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded. The intravascular guiding catheter is a cardiovascular catheter with GMDN-code 17846 (and ECRI-code 17846) with GMDN definition: A flexible tube with a central lumen used for the percutaneous, transluminal passage and placement of guidewires and diagnostic and therapeutic devices within the vascular system. After the tube is inserted in position, a guidewire is advanced through its lumen and tracked over by a diagnostic / therapeutic device (e.g., balloon dilatation catheter, stent and delivery system, or embolization device) to the intended location. The distal section of the tube can have a variety of preformed shapes (e.g., straight, multi- purpose, hockey stick, renal double curve); This is a single-use device. (Reference www.GMDNagency.org).
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