The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Athletis Pta Balloon Dilatation Catheter.
| Device ID | K201170 |
| 510k Number | K201170 |
| Device Name: | Athletis PTA Balloon Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 |
| Contact | Jennifer Mrkvicka |
| Correspondent | Jennifer Mrkvicka Boston Scientific Corporation 3 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 | 2020-05-01 |
| Decision Date | 2020-09-15 |