The following data is part of a premarket notification filed by Ostial Corporation with the FDA for Flash-c Ptca Balloon Dilatation Catheter- 4.0mm X 14mm X 135cm -4.0mm X 19mm X 135cm- 4.5mm X 14mm X 135cm-4.5mm X 19mm.
| Device ID | K113775 |
| 510k Number | K113775 |
| Device Name: | FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-22 |
| Decision Date | 2012-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M917OCB5014BA0 | K113775 | 000 |
| M917OCB4514BA0 | K113775 | 000 |
| M917OCB4014BA0 | K113775 | 000 |