The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Apdl Drainage Catheter System, Flexima Apdl Drainage Catheter System, Flexima Apdl Drainage Catheter System Kit With Dissolving Tip, Flexima Apdl Drainage Catheter System With Dissolving Tip, Flexima Apd Drainage Catheter System, Flexima Apd Drainage.
| Device ID | K211934 |
| 510k Number | K211934 |
| Device Name: | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit With Dissolving Tip, Flexima APDL Drainage Catheter System With Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage |
| Classification | Stent, Ureteral |
| Applicant | Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 |
| Contact | Liz Johnston |
| Correspondent | Liz Johnston Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-22 |
| Decision Date | 2022-11-10 |