# K140345: The Sherlock 3CG Tip Confirmation System (TCS)

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 14, 2014 after 31 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: 11 generations back to K001901 (2000). 34 ancestors in all.
2 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)
- K113808: The Sherlock 3CG Tip Confirmation System (TCS), C.R. Bard, Inc. (2012) Summary page 1.

## Most influential descendants
- K180560: Sherlock 3CG+ T ip Confirmation System (2018), 1 descendant of its own
- K252792: PM2™ System with ECGuide™ Connector (2025), 0 descendants of its own

## Indications for use
The Sherlock 3CC Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CGTM TCS provides real-time P1CC tip location information by using passive magnet tracking and the patient's cardiac-electrical activity (ECG). \Vhen relying on the patient's ECG signal, the Sherlock 3CGTIM TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for P1CC tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atria] fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catheter insertion, the use of an additional method is required to confirm P1CC tip location.

Source page: https://510kreport.com/device/K140345
Methodology: https://510kreport.com/methodology