# K140270: Nexus Midline CT Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Health Line International Corporation
- Decided: Aug 20, 2014 after 198 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K001901 (2000). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101329: Synergy CT Picc, Health Line International Corporation (2010) Summary page 4.
- K130034: Uni-Picc, Health Line International Corporation (2013) Summary page 5.
- K091586: Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen, Medcomp (2009) Summary page 5.
- K121073: Powerglide Midline Catheter, C.R. Bard, Inc. (2012) Summary page 5.

## Most influential descendants
- K200263: Health Line CT Midline Catheter (2020), 0 descendants of its own

## Indications for use
The NEXUS™ MIDLINE CT CATHETER is indicated for short term (less than 30 days) peripheral access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The NEXUS™ MIDLINE CT CATHETER is suitable for use with power injectors. For maximum flow rate and maximum pressure that can be used during power injection, please refer to the following: Catheter Size Priming Volume | Max Labeled Flow Rate (ml/sec)* Max Internal Catheter Rated Burst Pressure at Max Flow Rate Pressure (psi) (psi)** 3Fr Single Lumen 0.29 1 167 251 4Fr Single Lumen 0.37 5 164 299 4Fr Dual Lumen 0.35/0.35 3 173/173 299 SFr Single Lumen 0.38 9 112 300 5 Fr Dual Lumen 0.37/0.37 5 179/179 299 * Pressurized flow rates are determined with pump safety cut-off at 300 psi using viscous fluid at 11.8 centipoise (cP) and represents approximate flow capability of power injection of contrast media. ** Max Burst Pressure is the static burst pressure failure point of the catheter when the lumen is completely occluded. WARNING: Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.

Source page: https://510kreport.com/device/K140270
Methodology: https://510kreport.com/methodology