# K063355: D-Line Catheter ST, Double Lumen ST; Extra Flow

- Pathway: 510(k) (Traditional)
- Applicant: Novosci Corp.
- Decided: Jul 27, 2007 after 262 days
- Product code: MPB (Catheter, Hemodialysis, Non-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: 2 generations back to K941851 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963446: Kendall Dual Lumen Catheter, Kendall Healthcare Products Co. Div.Of Tyco Health (1997) Summary page 1.
- K030209: Mahurkar Oplus Catheter, Model 13.5 FR, The Kendall Company (2003) Summary page 1.
- K974236: Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL Soft-Line Double Lumen Catheter, 20CM SB, Medical Components, Inc. (1999) Summary page 1.

## Most influential descendants
- K102833: Disposable Hemodialysis Access Catheter Sets (2011), 0 descendants of its own

## Indications for use
The Dual Lumen Short Term Hemodialysis and Extra Flow (EF) Short Term Hemodialysis catheters are indicated for use in hemodialysis, hemoperfusion and apheresis for short-term duration of less than 30 days via the subclavian, femoral or jugular vein

Source page: https://510kreport.com/device/K063355
Methodology: https://510kreport.com/methodology