(15 days)
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheter is designed to establish peripheral access to the venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal.
This product is effective for venous access in adults, children and infants who require intravenous therapy.
Warning: The PASV™ Dual Lumen Peripherally Inserted Midline Catheter is NOT indicated for infusion of the following:
- Hypertonic nutrition solutions with final glucose concentrations . greater than 10%
- Continuously infused Vesicant Drugs .
- Any medication contraindicated for infusion into the peripheral . system
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheters have the same intended use as our Single Lumen Midline Catheters (K963215).
PASV™ Dual Lumen Peripherally Inserted Midline Catheter
The provided text is a 510(k) clearance letter from the FDA for a medical device called the PASV™ Dual Lumen Peripherally Inserted Midline Catheter. It indicates that the device has been found substantially equivalent to previously marketed devices. However, this document does not contain any information regarding the acceptance criteria, study design, or performance data for the device.
Therefore, I cannot extract the requested information from the provided text. The document is solely a regulatory clearance letter and not a technical study report.
§ 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).