Company ยท US
Ostial Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2016. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 16, 2016 | K152485 | FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System Ostial Corporation | LOX |
| May 8, 2015 | K150946 | 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 Ostial Corporation | LIT |
| Jul 2, 2014 | K133861 | FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM Ostial Corporation | LIT |
| Aug 6, 2013 | K131450 | 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 | LOX |
| Oct 11, 2012 | K122178 | FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 Ostial Corporation | LOX |
| Sep 5, 2012 | K122379 | FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM Ostial Corporation | LIT |
| Jun 29, 2012 | K121175 | FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM Ostial Corporation | LIT |
| Jun 29, 2012 | K113775 | 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 | LOX |
| Jun 29, 2012 | K113582 | ARCHSTENT BILIARY SYSTEM Ostial Corporation | FGE |
| Mar 29, 2012 | K120738 | FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM Ostial Corporation | LIT |
| Aug 17, 2011 | K111284 | FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM Ostial Corporation | LOX |
| Feb 25, 2011 | K102482 | FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM Ostial Corporation | LIT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2021 | Ostial Corporation FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA Terminated |
LIT | K122379 |