The following data is part of a premarket notification filed by Ostial Corporation with the FDA for Flash Pta Balloon Dilatation Catheter 5mm X 19mm X 135cm; Flash Pta Balloon Dilatation Catheter 6mm X 19mm X 135cm.
| Device ID | K102482 |
| 510k Number | K102482 |
| Device Name: | FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | OSTIAL CORPORATION 510 CLYDE AVENUE Mountain View, CA 94043 |
| Contact | Eric Ankerud, Jd |
| Correspondent | Eric Ankerud, Jd 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 | 2010-08-30 |
| Decision Date | 2011-02-25 |
| Summary: | summary |