# K811378: Percutaneous Draining Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Tech, Inc.
- Decided: Jun 2, 1981 after 18 days
- Product code: GBW (Catheter, Peritoneal)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: 6 (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
- Dec 12, 2017 · Class II · Z-1099-2018: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
- Mar 18, 2009 · Not classified · Z-1336-2009: 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-1338-2009: 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-1335-2009: 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-1334-2009: 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
- Aug 10, 2006 · Not classified · Z-1499-06: Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.

Source page: https://510kreport.com/device/K811378
Methodology: https://510kreport.com/methodology