Ostial Corporation is one of 15082 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ostial Corporation - FDA 510(k) Cleared Devices
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
Ostial Corporation has 11 FDA 510(k) cleared cardiovascular devices. Based in Mountain View, US.
Historical record: 11 cleared submissions from 2011 to 2016.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Ostial Corporation
12 devices
Cleared
Feb 16, 2016
FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System -...
Cardiovascular
169d
Cleared
May 08, 2015
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x...
Cardiovascular
30d
Cleared
Jul 02, 2014
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM...
Cardiovascular
195d
Cleared
Aug 06, 2013
FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X...
Cardiovascular
78d
Cleared
Oct 11, 2012
FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA...
Cardiovascular
80d
Cleared
Sep 05, 2012
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON...
Cardiovascular
30d
Cleared
Jun 29, 2012
ARCHSTENT BILIARY SYSTEM
Gastroenterology & Urology
207d
Cleared
Jun 29, 2012
FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM...
Cardiovascular
190d
Cleared
Jun 29, 2012
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
Cardiovascular
72d
Cleared
Mar 29, 2012
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
Cardiovascular
17d
Cleared
Aug 17, 2011
FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
Cardiovascular
103d
Cleared
Feb 25, 2011
FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM
Cardiovascular
179d