# K033862: Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String Lock

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corp.
- Decided: Feb 14, 2005 after 430 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
Longest line of descent: 1 generation back to K003753 (2001). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003753: GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking Pigtail, GP General Purpose Drainage  Cathe, Uresil Corp. (2001) Summary page 1.

## Most influential descendants
- K200103: BIOTEQ Drainage Catheter Set (One Step Type) (2020), 3 descendants of its own
- K210419: BIOTEQ Drainage Catheter BT-PDS-series (2022), 2 descendants of its own
- K254179: Drainage Catheter (2026), 0 descendants of its own
- K251019: BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (2025), 0 descendants of its own

## Indications for use
BIOTEQ® Pigtail Drainage Catheter Set (One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders and nephrostomies.

Source page: https://510kreport.com/device/K033862
Methodology: https://510kreport.com/methodology