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Sapiens Tip Confirmation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112744

by C. R. Bard, Inc.

Identifiers

510(k) Number
K112744 FDA 510(k)
FDA Product Code
LJS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5970 FDA 510(k)
Regulation Number
880.5970 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sapiens Tip Confirmation System is a device used for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). It provides real-time PICC tip location information by using the patient's cardiac electrical activity. The system consists of a PC netbook running Sapiens TCS software, an ECG module, ECG leads connection, and optional printer and remote control.

The device is supplied as a system that connects to a stylet inserted into a central venous catheter. It is a Class 2 device with FDA 510(k) clearance (K112744) and is intended for use in general hospital settings. The system is not described as single-use or reusable, and no specific MRI safety information is provided in the data.

Frequently asked questions

What is the Sapiens Tip Confirmation System used for?

The Sapiens Tip Confirmation System is designed for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). It provides real-time information about PICC tip location by utilizing the patient's cardiac electrical activity to ensure proper placement.

What components are included in the Sapiens Tip Confirmation System?

The system consists of a PC netbook running Sapiens TCS software, an ECG module, ECG leads connection, and optional accessories including a printer and remote control. It connects to a stylet inserted into a central venous catheter to provide real-time guidance.

Is the Sapiens Tip Confirmation System single-use or reusable?

The device data does not specify whether the Sapiens Tip Confirmation System is single-use or reusable. As a Class 2 device with FDA 510(k) clearance, it is intended for use in general hospital settings, but the specific usage instructions regarding reusability are not provided in the available information.

What is the regulatory status of the Sapiens Tip Confirmation System?

The Sapiens Tip Confirmation System is a Class 2 medical device that received FDA 510(k) clearance with number K112744 on October 20, 2011. It was determined to be substantially equivalent to other devices for guidance and positioning of PICCs using cardiac electrical activity.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF 21 CFR 807.92 Sapiens* Tip Confirmation System, K112744 FDA 510(k) - SAPIENS TIP CONFIRMATION SYSTEM, SAPIENS TIP CONFIRMATION SYSTEM (K112744) — FDA 510 (k) | Innolitics, Sherlock 3CG+™ Tip Confirmation System - BD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K112744 24 fields · synced Sep 26, 2026