The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for 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 Percuta.
| Device ID | K162350 |
| 510k 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 Percuta |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 -1566 |
| Contact | Ka Zoua Xiong |
| Correspondent | Ka Zoua Xiong Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 -1566 |
| Product Code | LIT |
| Subsequent Product Code | DQY |
| Subsequent Product Code | FGE |
| Subsequent Product Code | LOX |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-23 |
| Decision Date | 2016-11-04 |
| Summary: | summary |