# K143238: C3 Wave

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp ( Medical Components)
- Decided: Apr 24, 2015 after 163 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). 33 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140799: Celerity Sysyem, Medcomp (Medical Components, Inc.) (2014) Summary page 4.

## Most influential descendants
- K170934: C3 Wave System (2017), 2 descendants of its own
- K241587: pilot TLS (2025), 0 descendants of its own
- K180567: C3 Wave System (2018), 0 descendants of its own

## Indications for use
The C3 Wave System is indicated for use as a supplemental aid in positioning for Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient’s cardiac electrical activity. Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.g., Chest X-Ray, Fluoroscopy). Note: Limiting, but not contraindicated. situations for this technique are patients where cardiac rhythms may change presentation of the P wave: atrial fibrillation,atrial flutter, severe tachycardia. pacemaker driven rhythm, and cronic obstructive pulmonary disease (COPD). Such patients are easily identified prior to PICC insertion. Use of additional confirmation method is necessary to confirm catheter tip location.

Source page: https://510kreport.com/device/K143238
Methodology: https://510kreport.com/methodology