The following data is part of a premarket notification filed by Boston Scientific Limited with the FDA for 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter.
| Device ID | K151253 |
| 510k Number | K151253 |
| Device Name: | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | BOSTON SCIENTIFIC LIMITED BALLYBRIT BUSINESS PARK GALWAY Galway, IE |
| Contact | Lisa Mee |
| Correspondent | Lisa Mee BOSTON SCIENTIFIC LIMITED BALLYBRIT BUSINESS PARK GALWAY Galway, IE |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-12 |
| Decision Date | 2015-06-10 |
| Summary: | summary |