The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Symmetry Balloon Dilatation Catheter.
| Device ID | K060959 |
| 510k Number | K060959 |
| Device Name: | SYMMETRY BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Boston Scientific Corporation TWO SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Angela Byland |
| Correspondent | Angela Byland Boston Scientific Corporation TWO SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-07 |
| Decision Date | 2006-04-12 |
| Summary: | summary |