# K944290: Catheters, Biliary Catheters, Urological

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 8, 1994 after 97 days
- Product code: FFA (Tube, Drainage, Suprapubic)
- Device class: 2
- Regulation: 21 CFR 876.5090
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 5 cite it directly.
0 of 28 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
- K965147: Biliary Stent, Biliary Stent System, Biliary Endoprosthesis (1997), 17 descendants of its own
- K101314: Advanix Biliary Stent with Naviflex RX Delivery System (2010), 14 descendants of its own
- K093392: Multipurpose, Nephrostomy and Biliary Drainage Catheters (2009), 5 descendants of its own
- K133700: Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and Pushers (2014), 4 descendants of its own
- K193600: EndoGI Biliary Stent System (2020), 3 descendants of its own

## Recalls of this device
- Mar 18, 2009 · Not classified · Z-1340-2009: 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-1333-2009: 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-1332-2009: 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-1331-2009: 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
- Sep 21, 2006 · Not classified · Z-0081-2007: Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.

Source page: https://510kreport.com/device/K944290
Methodology: https://510kreport.com/methodology