(103 days)
The Cook Central Venous Catheter with or without Heparin is used for:
- Continuous or intermittent drug infusions .
- Central venous blood pressure monitoring (CVP) .
- Acute hyperalimentation .
- Blood sampling .
- Delivery of whole blood or blood products .
- Power injection of contrast media* .
The device is a short-term use catheter.
- The flow rate of the Cook Central Venous Catheters may not exceed 10 ml/sec.
The Cook Spectrum and Spectrum Glide Central Venous Catheter is used for:
- Continuous or intermittent drug infusions ●
- Central venous blood pressure monitoring (CVP) .
- . Acute hyperalimentation
- Blood sampling .
- Delivery of whole blood or blood products .
- Power injection of contrast media* .
The activity of the antimicrobial agents, minocycline and rifampin, is localized at the internal and external catheter surface and helps to provide protection against catheterrelated bloodstream infections (CRBSI). It is not intended for treatment of existing infection. The device is a short-term use catheter.
- The flow rate of the Cook Central Venous Catheters may not exceed 10 ml/sec.
Cook Incorporated's Central Venous Catheters incorporate separate, non-communicating vascular access lumens within a single catheter body. These catheters may be impregnated with minocycline and rifampin to help provide protection against catheterrelated blood stream infections (CRBSI).
Several sizes are available to allow physicians to choose the catheter that matches anatomical needs of the patient, as well as the number of lumens required for treatment.
This document does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a 510(k) summary for Cook Incorporated Central Venous Catheters, primarily focusing on general device information, intended use, technological characteristics, and regulatory correspondence.
It states:
- "There have been no changes in the design, dimensions, or materials of the device."
- "This submission is for an expansion in the indications for use-a change in labeling only-for Cook Central Venous Catheters. There has been no change to the design, dimensions, or materials of the existing on-market devices."
Therefore, no new studies, acceptance criteria, or performance data related to device effectiveness or safety are presented in this document. The submission is a regulatory update based on existing device characteristics and an expansion of approved uses, not a study of new performance metrics.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).