The following data is part of a premarket notification filed by Ostial Corporation with the FDA for 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.
| Device ID | K150946 |
| 510k Number | K150946 |
| Device Name: | 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 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-08 |
| Decision Date | 2015-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M917OTW7012BA0 | K150946 | 000 |
| M917OTW6012BA0 | K150946 | 000 |