Sherlock Tls Stylet, Sherlock Tls Detector
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063240 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 Tls Styplet is a device that provides internal reinforcement and stiffness to catheters during venotomy and contains passive magnets that generate a magnetic field. It is used with the Sherlock Tls Detector to provide real-time feedback on catheter tip location during PICC/CVC placement. The device is a type of catheter, intravascular, therapeutic, long-term greater than 30 days.
The Sherlock Tls Styplet and Detector are supplied for use in hospitals, long-term care, or home settings by clinicians to assist in PICC/CVC placement. The device has an FDA 510K authorization and is classified under regulation number 880.5970. It is a single device with a specific product code, LJS, and is not described as single-use or reusable, or as having specific storage or MRI safety requirements.
Frequently asked questions
What is the Sherlock Tls Styplet used for?
The Sherlock Tls Styplet is used to provide internal reinforcement and stiffness to catheters during venotomy and to assist in PICC/CVC placement with real-time feedback on catheter tip location.
Is the Sherlock Tls Styplet single-use or reusable?
The device is not described as single-use or reusable in the provided data.
What settings can the Sherlock Tls Styplet be used in?
The device is supplied for use in hospitals, long-term care, or home settings by clinicians.
What is the product code for the Sherlock Tls Styplet?
The product code for the Sherlock Tls Styplet is LJS.
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 TLS STYLET, SHERLOCK TLS DETECTOR (K063240) — FDA 510 (k ..., SHERLOCK TIP LOCATION SYSTEM (TLS) (K060341) — FDA 510 (k) | Innolitics, PDF 000016 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063240 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K063240 24 fields · synced Sep 22, 2026