# K964757: Contidrain Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Contimed, Inc.
- Decided: Jun 25, 1997 after 210 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K861478 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861478: Bard Double Pigtail Ureteral Stent, C.R. Bard, Inc. (1986) Summary page 1.
- K950300: Bard Flexible Tip Ureteral Catheter, C.R. Bard, Inc. (1995) Summary page 1.

## Indications for use
The ContiDrain™ Catheter is indicated for continuous urine drainage.

Source page: https://510kreport.com/device/K964757
Methodology: https://510kreport.com/methodology