Ostial Corporation · Class II · Cleared Sep 5, 2012
| K-number | K122379 |
| Device name | FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM |
| Applicant | Ostial Corporation |
| Product code | LIT |
| Device class | Class II |
| Decision date | Sep 5, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
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