# K170934: C3 Wave System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc (Dba Medcomp_
- Decided: Dec 6, 2017 after 251 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 34 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K143238: C3 Wave, Medcomp ( Medical Components) (2015) Summary page 4.

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

## Recalls of this device
- Oct 1, 2018 · Class II · Z-0222-2020: When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If

## Indications for use
The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave provides real-time catheter tip location information by displaying changes in the patient’s cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients. 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 -Chronic obstructive pulmonary disease (COPD) Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

Source page: https://510kreport.com/device/K170934
Methodology: https://510kreport.com/methodology