510(k) required for Utah Medical Products' Cordguard II:
This article was originally published in Clinica
Executive Summary
The US CDRH has advised Utah Medical Products (US) that it will have to submit new 510(k) premarketing submission for its new version of Cordguard I. Utah Medical had intended to begin sales of the Cordguard II device later this month but decided to check with the agency that the modified device did not require regulatory clearance. The CRDH informed the company on September 20th that it needs formal documentation that the device is substantially equivalent to the original device. Cordguard II has been designed to reduce clinician exposure to potentially infected blood splatters while collecting neonatal blood samples for diagnosis.