VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charg…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211589 FDA 510(k)
- FDA Product Code
- DPW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2100 FDA 510(k)
- Regulation Number
- 870.2100 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VascuChek system is a handheld vascular Doppler device designed to assess blood flow within vessels using 8 MHz Doppler technology. It functions as a portable alternative to traditional Doppler systems, eliminating the need for bulky transceivers and tethered probes while providing real-time audio feedback of vascular activity. This system is classified as a blood flowmeter under cardiovascular medical devices and is intended for intraoperative and clinical use.
The VascuChek Kit includes a cordless handheld unit, a transceiver, sterile single-use surgical or clinical probes, and a charger. The device is intended for single-patient use, ensuring sterility and reliability in both surgical and clinical settings. It operates without MRI restrictions and is authorized under FDA 510(k) clearance (K211589) as substantially equivalent to existing blood flowmeter devices. Components are supplied as a complete kit for immediate clinical or intraoperative use.
Frequently asked questions
What is the VascuChek system used for?
The VascuChek system is designed to assess blood flow within vessels using 8 MHz Doppler technology. It provides real-time audio feedback of vascular activity, making it ideal for intraoperative and clinical use. This handheld device replaces traditional Doppler systems by eliminating bulky transceivers and tethered probes, offering a portable alternative for quick and reliable vascular assessments.
How is the VascuChek Kit supplied, and what does it include?
The VascuChek Kit is supplied as a complete package for immediate clinical or intraoperative use. It includes a cordless handheld unit, a transceiver, sterile single-use surgical or clinical probes, and a charger. The sterile probes are designed for single-patient use, ensuring sterility and reliability in both surgical and clinical environments.
Are the probes reusable or single-use, and why?
The VascuChek surgical and clinical probes are single-use only. This design ensures sterility and reduces the risk of cross-contamination between patients, which is critical in clinical and intraoperative settings where hygiene and reliability are paramount. Single-use probes also eliminate the need for reprocessing, streamlining workflow.
What are the key specifications of the VascuChek system?
The VascuChek system operates using 8 MHz Doppler technology and is classified as a blood flowmeter under cardiovascular medical devices. It is authorized under FDA 510(k) clearance (K211589) as substantially equivalent to existing blood flowmeter devices. The system is portable, cordless, and does not have MRI restrictions, making it versatile for various clinical environments.
How should the VascuChek system be stored?
While the device data does not specify storage conditions explicitly, best practices for similar medical devices recommend storing the handheld unit, transceiver, and charger in a clean, dry environment away from direct sunlight or extreme temperatures. The single-use sterile probes should remain in their sealed packaging until use to maintain sterility. Always follow manufacturer guidelines for optimal performance and longevity.
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: VascuChek® Handheld Vascular Doppler | By Remington Medical, VascuChek® Handheld Vascular Doppler| Intraoperative & Clinical Use, VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211589 | Class II | Active |
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Manufacturer
- Manufacturer
- Remington Medical, Inc.
Sources (1)
- FDA 510(k) K211589 24 fields · synced Oct 5, 2026