The following data is part of a premarket notification filed by Ostial Corporation with the FDA for Flash-c Ptca Balloon Dilatation Catheter - 4mm X 14mm X 135cm, Flash-c Ptca Balloon Dilatation Catheter - 4mm X 19mm X 1.
| Device ID | K122178 |
| 510k Number | K122178 |
| Device Name: | FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| 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 | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-23 |
| Decision Date | 2012-10-11 |
| Summary: | summary |