# K893439: Hemo-Cath Silicone Double Lumen Cath SL28C & SL40C

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Jun 13, 1989 after 41 days
- Product code: LFJ (Catheter, Subclavian)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K113487: Hemo-Cath 10F, Hemo-Cath 12.5F (2012), 3 descendants of its own
- K130851: Cascade Hemodialysis/Apheresis Catheter (2014), 1 descendant of its own
- K241581: Hemodialysis Catheter (2025), 0 descendants of its own
- K121383: PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components) (2012), 0 descendants of its own
- K952660: Braun Hemodialysis Catheter (1996), 0 descendants of its own

## Recalls of this device
- Mar 13, 2019 · Class II · Z-1149-2019: Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
- Mar 13, 2019 · Class II · Z-2217-2019: Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
- Mar 13, 2019 · Class II · Z-2216-2019: Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
- Mar 13, 2019 · Class II · Z-2215-2019: Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
- 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/K893439
Methodology: https://510kreport.com/methodology