Sherlock 3CG Tip Positioning System Stylet
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172397 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 Sherlock 3CG Tip Positioning System Stylet is a Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, designed for precise tip positioning within central venous access devices (CVADs). It employs magnetic tracking and ECG-based technology to confirm catheter placement, reducing reliance on fluoroscopy or chest X-rays for verification.
This single-use stylet is intended for use in general hospital settings and integrates with the Sherlock 3CG system to provide real-time tip location feedback via magnetic tracking and P-wave analysis. Supplied sterile, it requires no additional regulatory approval beyond its FDA 510(k) clearance under Special Review (K172397). Compatible with various catheter types, it is stored under standard medical device conditions and must be handled in accordance with aseptic techniques.
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: Sherlock 3CG+™ Tip Confirmation System - BD, Sherlock 3CG™ Diamond Tip Confirmation System - BD, BARD SHERLOCK 3CG INSTRUCTIONS FOR USE MANUAL Pdf Download, Sherlock 3CG Tip Positioning System Stylet (K142267) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172397 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K172397 24 fields · synced Sep 19, 2026