# K981258: Manan Malecot Basket Drainage Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Apr 22, 1998 after 16 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
Longest line of descent: 1 generation back to K954147 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954147: Manan Malecot Basket Drainage Catheter, Manan Medical Products, Inc. (1996) Summary page 1.

## Indications for use
The Manan™ Malecot Basket Drainage Catheter is for percutaneous nephrostomy and abcess drainage.

Source page: https://510kreport.com/device/K981258
Methodology: https://510kreport.com/methodology