The following data is part of a premarket notification filed by Ostial Corporation with the FDA for Flash Pta Balloon Dilatation Catheter - 4mm X 14mm X 135cm, Flash Pta Balloon Dilatation Catheter - 4mm X 19mm X 135cm.
| Device ID | K122379 |
| 510k Number | K122379 |
| Device Name: | FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2012-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M917OAB7019BA0 | K122379 | 000 |