UPDATE: Sanovas launches 1st phase of Vas Zeppelin Smart Catheter clearance push
Sanovas files a 510(k) clearance application with the FDA for its Vas Zeppelin Smart Catheter, saying further applications are coming for its suite of pulmonary medical devices.
Sanovas said it's asked the FDA for 510(k) clearance for its Vas Zeppelin Smart Catheter, designed to diagnose and treat chronic pulmonary conditions and lung cancer.
The Sausalito, Calif.-based medical device company bills the device as "among the smallest interventional catheters," saying it's designed to "overcome the complexity and procedural risks associated with pulmonary intervention," according to a press release.
CEO Larry Gerrans told MassDevice.com that Sanovas is pursuing a 3-phase approach to getting its 6 product lines and more than 37 products through the federal watchdog agency.