The following data is part of a premarket notification filed by Ostial Corporation with the FDA for Flash Ostial System Otw-7.0mmx17mmx135cm, Flash Ostial System Otw-7.0mmx17mmx80cm.
| Device ID | K133861 |
| 510k Number | K133861 |
| Device Name: | FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | OSTIAL CORPORATION 1221 INNSBRUCK DRIVE Sunnyvale, CA 94089 |
| Contact | Jake Wolenberg |
| Correspondent | Jake Wolenberg OSTIAL CORPORATION 1221 INNSBRUCK DRIVE Sunnyvale, CA 94089 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-19 |
| Decision Date | 2014-07-02 |
| Summary: | summary |