Medical Device Manufacturer · US , Mountain View , CA

Ostial Corporation - FDA 510(k) Cleared Devices

12 submissions · 11 cleared · Since 2011

Recent clearances: FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm, FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM

12

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ostial Corporation Gastroenterology & Urology ✕

1 devices

1-1 of 1

Cleared Jun 29, 2012

ARCHSTENT BILIARY SYSTEM

Gastroenterology & Urology · 207d