# K890029: Hemo-Cath Silicone Double Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Apr 17, 1989 after 103 days
- Product code: LFJ (Catheter, Subclavian)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (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
- Jan 21, 2015 · Class II · Z-1083-2015: Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chlor

Source page: https://510kreport.com/device/K890029
Methodology: https://510kreport.com/methodology