Boston Scientific Corporation · Class II · Cleared Nov 4, 2016
| K-number | K162350 |
| Device name | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 |
| Applicant | Boston Scientific Corporation |
| Product code | LIT |
| Device class | Class II |
| Decision date | Nov 4, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
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