Tag: 510(k)
Okami Medical announces FDA 510(k) clearance of the LOBO-5 vascular occluder
Okami Medical has revealed the expansion of its LOBO vascular occlusion system product line with US Food and Drug Administration (FDA) 510(k) clearance of...
Infinity angioplasty balloon catheter receives 510(k) clearance
The Infinity Angioplasty Balloon Company has announced that its balloon platform—the Infinity angioplasty balloon catheter—has been cleared by the US Food and Drug Administration...
FDA issues guidance on PTA balloon and specialty catheter 510(k) submissions
The US Food and Drug Administration (FDA) has released draft guidance detailing the information device-makers should include in 510(k) submissions of catheter-based devices intended...
Okami Medical announces FDA 510(k) clearance and patent for the LOBO...
Okami Medical today announced 510(k) clearance by the US Food and Drug Administration (FDA) and initial launch of the LOBO vascular occlusion system.
The company...
First patients treated in United States with OrbusNeich Teleport Microcatheter
The first patients in the United States have been treated using the OrbusNeich Teleport Microcatheter (Teleport; Cardiovascular Systems), which recently received US Food and...
BTG receives FDA 510(k) clearance for EKOS Control Unit 4.0
BTG has announced US Food and Drug Administration (FDA) 510(k) clearance has been granted to the EKOS Control Unit 4.0. The EKOS system includes an ultrasonic...
Merit Medical receives 510(k) clearance for the SwiftNINJA steerable microcatheter
Merit Medical Systems has received 510(k) clearance for the SwiftNINJA steerable microcatheter, covering peripheral and coronary applications. With the exception of Japan, Merit has...
