FDA 510(k) Applications Submitted by OSTIAL CORPORATION
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K102482 |
08/30/2010 |
FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM |
OSTIAL CORPORATION |
| K150946 |
04/08/2015 |
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 |
OSTIAL CORPORATION |
| K131450 |
05/20/2013 |
FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 |
OSTIAL CORPORATION |
| K152485 |
08/31/2015 |
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 |
OSTIAL CORPORATION |
| K133861 |
12/19/2013 |
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM |
OSTIAL CORPORATION |
| K113582 |
12/05/2011 |
ARCHSTENT BILIARY SYSTEM |
OSTIAL CORPORATION |
| K120738 |
03/12/2012 |
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM |
OSTIAL CORPORATION |
| K121175 |
04/18/2012 |
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM |
OSTIAL CORPORATION |
| K122178 |
07/23/2012 |
FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 |
OSTIAL CORPORATION |
| K122379 |
08/06/2012 |
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM |
OSTIAL CORPORATION |
| K113775 |
12/22/2011 |
FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM |
OSTIAL CORPORATION |
| K111284 |
05/06/2011 |
FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM |
OSTIAL CORPORATION |
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