The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Spyscope Ds Access And Delivery Catheter, Spyscope Ds Ii Access And Delivery Catheter, Spyglass Ds Digital Controller.
| Device ID | K183636 |
| 510k Number | K183636 |
| Device Name: | SpyScope DS Access And Delivery Catheter, SpyScope DS II Access And Delivery Catheter, SpyGlass DS Digital Controller |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Carter Navarro |
| Correspondent | Carter Navarro Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | FBN |
| Subsequent Product Code | KQM |
| Subsequent Product Code | NTN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-01-22 |
| Summary: | summary |