# K900205: Drainage Catheters W/a Dissolvable Tip

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 20, 1991 after 581 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Mar 18, 2009 · Not classified · Z-1341-2009: Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, suture
- Mar 18, 2009 · Not classified · Z-1343-2009: Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, suture

Source page: https://510kreport.com/device/K900205
Methodology: https://510kreport.com/methodology