# K211934: 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

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Nov 10, 2022 after 506 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924608 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924608: Hydrogel Coated Percuflex (R) Drainage Catheters, Boston Scientific Corp (1994) Summary page 10.
- K944290: Catheters, Biliary Catheters, Urological, Boston Scientific Corp (1994) Summary page 10.

## Recalls of this device
- Jul 18, 2024 · Class II · Z-3147-2024: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- Jul 18, 2024 · Class II · Z-3149-2024: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- Jul 18, 2024 · Class II · Z-3150-2024: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- Jul 18, 2024 · Class II · Z-3148-2024: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- Jul 18, 2024 · Class II · Z-3151-2024: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

## Indications for use
To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection. The vanSonnenberg™ Sump Catheter is designed for use as a percutaneously placed drain for intra-abdominal fluid collections. Such conditions include abscesses, cysts, pseudocysts, bilomas, hematomas, seromas, urinomas, or any loculated fluid collection.

Source page: https://510kreport.com/device/K211934
Methodology: https://510kreport.com/methodology