# K913517: Isolate Infusion Cathetr System

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Mfg., Inc.
- Decided: Nov 5, 1991 after 90 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
95 later devices descend from it; 6 cite it directly.
2 of 96 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
- K013635: Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length) (2002), 75 descendants of its own
- K021958: Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM Catheter Length 10CM Infusion H (2002), 57 descendants of its own
- K023514: Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length) (2002), 56 descendants of its own
- K030637: Ekos Peripheral Infusion System (2003), 50 descendants of its own
- K033214: Ekos Peripheral Infusion System (2003), 46 descendants of its own

Source page: https://510kreport.com/device/K913517
Methodology: https://510kreport.com/methodology