The following data is part of a premarket notification filed by Ostial Corporation with the FDA for Flash Pta Ballon Dilatation Catheter-5mm X 19mm X 135cm.
| Device ID | K121175 |
| 510k Number | K121175 |
| Device Name: | FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | OSTIAL CORPORATION 510 CLYDE AVENUE Mountain View, CA 94043 |
| Contact | Kaitlin Von Hoffmann |
| Correspondent | Kaitlin Von Hoffmann OSTIAL CORPORATION 510 CLYDE AVENUE Mountain View, CA 94043 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-18 |
| Decision Date | 2012-06-29 |
| Summary: | summary |