# K924608: Hydrogel Coated Percuflex (R) Drainage Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jan 26, 1994 after 502 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 8 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K141344: Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage Stent System (2014), 6 descendants of its own
- 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 (2022), 0 descendants of its own
- K200260: Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System (2021), 0 descendants of its own
- K201436: Vortek Single Loop Ureteral Stent (2021), 0 descendants of its own
- K183051: Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K924608
Methodology: https://510kreport.com/methodology