The following data is part of a premarket notification filed by Ostial Corporation with the FDA for Flash-c Ptca Balloon Dilation Catheter - 5mm X 19mm X 135cm / 6mm X 19mm X 135cm.
| Device ID | K111284 |
| 510k Number | K111284 |
| Device Name: | FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | OSTIAL CORPORATION 510 CLYDE AVENUE Mountain View, CA 94043 |
| Contact | Mark Smutka |
| Correspondent | Mark Smutka OSTIAL CORPORATION 510 CLYDE AVENUE Mountain View, CA 94043 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-06 |
| Decision Date | 2011-08-17 |
| Summary: | summary |