# K072499: Novoflo Catheter LT

- Pathway: 510(k) (Traditional)
- Applicant: Novosci, Inc.
- Decided: Oct 30, 2007 after 55 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972207 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994105: Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40, Medical Components, Inc. (2001) Summary page 1.
- K030502: 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55, Medcomp (2003) Summary page 1.

## Indications for use
The NovoFiOTM Catheter LT Dual Lumen Long Term Hemodialysis Catheters are indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required. Catheters greater than 40cm in length are intended for femoral vein insertion

Source page: https://510kreport.com/device/K072499
Methodology: https://510kreport.com/methodology