Ostial Corporation

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
12
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2309-2021Class IIFLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BAJuly 14, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K152485FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASFebruary 16, 2016
K150946FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH OstMay 8, 2015
K133861FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CMJuly 2, 2014
K131450FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINIAugust 6, 2013
K122178FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHEOctober 11, 2012
K122379FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - September 5, 2012
K113775FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM XJune 29, 2012
K121175FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CMJune 29, 2012
K113582ARCHSTENT BILIARY SYSTEMJune 29, 2012
K120738FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CMMarch 29, 2012
K111284FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CMAugust 17, 2011
K102482FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM February 25, 2011