# K954147: Manan Malecot Basket Drainage Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Manan Medical Products, Inc.
- Decided: Mar 26, 1996 after 203 days
- Product code: FEW (Catheter, Malecot)
- Device class: 2
- Regulation: 21 CFR 876.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K981258: Manan Malecot Basket Drainage Catheter (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K954147
Methodology: https://510kreport.com/methodology