(108 days)
The VasoPress Sequential DVT Pump is an external pneumatic compression device for use with VasoPress Sequential Garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
The VasoPress Sequential DVT Pump is an external pneumatic compression device for use with VasoPress Sequential Garments.
The provided documents are a letter from the FDA to Compression Therapy Concepts, Inc. regarding the 510(k) premarket notification for the VasoPress Sequential DVT Pump, and the "Indications for Use Statement" for the same device. These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically found in a study report or clinical trial summary.
Therefore, I cannot provide the requested information based on the given text. The documents confirm the device's regulatory clearance and its intended use but do not describe the scientific studies or data supporting its performance.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).