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
FDA 510(k) Regulatory Record - Ostial Corporation Cardiovascular ✕
11 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
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