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 Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
FDA 510(k) clearance K211934 · decided 2022-11-10
Clearance details
- K-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 Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
- Applicant
- Boston Scientific Corporation
- Decision
- Unknown
- Date received
- 2021-06-22
- Decision date
- 2022-11-10
- Days to decision
- 506 days
- Clearance type
- Traditional
- Product code
- FAD
- Device class
- 2
- Regulation number
- 876.4620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF recall (Z-3147-2024) | Boston Scientific Corporation | 2024-09-13 |
| Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile dra recall (Z-3148-2024) | Boston Scientific Corporation | 2024-09-13 |
| Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To p recall (Z-3149-2024) | Boston Scientific Corporation | 2024-09-13 |
| vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number R recall (Z-3150-2024) | Boston Scientific Corporation | 2024-09-13 |
| VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provid recall (Z-3151-2024) | Boston Scientific Corporation | 2024-09-13 |
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