(68 days)
The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature.
The MTI Reinforced Infusion Catheter is a single-lumen plastic catheter designed to be introduced over a guidewire into the vasculature. Once positioned, various pharmacological agents may be delivered through a standard luer lock adapter at the proximal end. The infusion area of the Reinforced Infusion Catheter is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The Reinforced Infusion Catheters are available in a variety of infusion lengths.
Here's a breakdown of the acceptance criteria and study information for the Micro Therapeutics, Inc. Reinforced Infusion Catheter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria | Device Performance |
|---|---|
| Biocompatibility (in accordance with ISO 10993-1 for external communicating, blood contact, limited exposure ( |
§ 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).