The following data is part of a premarket notification filed by Ostial Corporation with the FDA for 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.
| Device ID | K152485 |
| 510k Number | K152485 |
| Device Name: | 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 |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| 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 | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2016-02-16 |
| Summary: | summary |