# K172397: Sherlock 3CG Tip Positioning System Stylet

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 29, 2017 after 52 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: 8 generations back to K001901 (2000). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091324: Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet, C.R. Bard, Inc. (2009) Summary page 5.

## Indications for use
Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), the Sherlock 3CG® TPS Stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.

Source page: https://510kreport.com/device/K172397
Methodology: https://510kreport.com/methodology