2 suppliers
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Address: 25134 Rye Canyon Loop, Suite 390, Santa Clarita, California 91355, USA
Products: General Medical Device, Implanted Subcutaneous Securement Catheter (FDA Code:
OKC), Custom Designed Medical Devices, ...
Incumed Research Organization specializes in implanted bio-materials and medical devices. We provide percutaneous implants, trans-catheter therapies, wound repair, soft tissue healing and extracellula
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Address: 181 Cheshire Land, Plymouth, Minnesota 55441, USA
www.interradmedical.com |
Phone: +1-(763)-225-6699
FDA Registration: 3007795799
Products: Catheter Accessories (FDA Code:
KGZ), General Medical Device, Implanted Subcutaneous Securement Catheter (FDA Code:
OKC), Subcutaneous Catheter Securement Systems, ...
Interrad Medical Inc. develops medical devices for use in minimally invasive interventional and surgical procedures. The Securacath System is a method for holding indwelling catheters in place. Curren
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2 Implanted Subcutaneous Securement Catheter suppliers
FDA Code / Regulation: OKC / 880.5970 A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.
Classification. Class II (special controls) Guidance Document: "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters."