# K131687: 6F X 60CM Triple Pro-Line CT Basic IR Set

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Aug 16, 2013 after 67 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 38 ancestors in all.
No later device cites it as a predicate yet.
2 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092347: Pro-Picc CT, Medcomp (2009)
- K121094: Medcomp Vascu-Picc & Midline Catheters, Medical Components, Inc. (2012) Summary page 1.
- K093309: Pro-Line CT (Basic Tray) Model MR28036101, Medcomp ( Medical Components) (2009) Summary page 1.
- K123617: 3F Pro-Picc, Medical Components, Inc. (2013) Summary page 1.

## Indications for use
The Medoomp® 6F Triple Pro-Line®DCT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for adiministering I.V. fluids, blood products, drugs, and parenteral nutrition solutions. as well as blood withdrawal, allows for central venous pressuire monitoring and power inection of contrast media. The maximum recommended infusion rate is 5cc,/sec.

Source page: https://510kreport.com/device/K131687
Methodology: https://510kreport.com/methodology