Endosonics Receives CE Marking for Key Products and Company-wide ISO 9001 Certification
EndoSonics Corp. announced that it has received approval to CE Mark certain key products under the European Union's Medical Device Directive (MDD) regulations. The newly CE-marked products include the company's Visions diagnostic imaging catheters, the Oracle In-Vision Imaging System, and the Cardiometrics FloWire, FloMap, WaveWire, and WaveMap functional assessment products.
The company also announced that it has received ISO 9001 certification at its Rancho Cordova, CA, headquarters and at EndoSonics B.V. in the Netherlands after successfully passing an ISO 9001/EN46001 audit in December 1997.
EndoSonics develops, manufactures and markets intravascular ultrasound (IVUS) imaging products and functional assessment products to assist in the diagnosis and treatment of cardiovascular and peripheral vascular disease.