510(k) for Minntech's hemoconcentrator:
This article was originally published in Clinica
Executive Summary
The FDA has cleared Minntech's Hemocor HPH 700 hemoconcentrator for use during open-heart surgery. The device removes excess fluid in the blood stream while retaining, or concentrating, the patient's red blood cells to minimise the need for donor blood. Due to its "no-rinse" technology, the product can be inserted into the bypass circuit at any time during the surgical procedure, the Minneapolis-based company said.