The following data is part of a premarket notification filed by Ostial Corporation with the FDA for Flash Mini Ostial System - 3.0mm X 135cm, Flash Mini Ostial System - 3.5mm X 8mm X 135cm, Flash Mini Ostial System - 4.0.
| Device ID | K131450 |
| 510k Number | K131450 |
| Device Name: | FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | OSTIAL CORPORATION 510 CLYDE AVENUE Mountain View, CA 94043 |
| Contact | Jake Wolenberg |
| Correspondent | Jake Wolenberg OSTIAL CORPORATION 510 CLYDE AVENUE Mountain View, CA 94043 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-20 |
| Decision Date | 2013-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M917OCB4508BA0 | K131450 | 000 |
| M917OCB4008BA0 | K131450 | 000 |
| M917OCB3508BA0 | K131450 | 000 |
| M917OCB3008BA0 | K131450 | 000 |