VascuChek Kit
The VascuChek Kit evaluates blood flow using Doppler ultrasound. A probe transmits ultrasound into tissue and detects the returning signal; the transceiver processes the Doppler shift into…
The VascuChek Kit evaluates blood flow using Doppler ultrasound. A probe transmits ultrasound into tissue and detects the returning signal; the transceiver processes the Doppler shift into an audio signal played through the speaker dock.
The clinical configuration includes a nonsterile probe, reusable transceiver and Bluetooth-enabled speaker dock. It provides noninvasive transcutaneous evaluation of blood flow in peripheral vessels.
Listed Item
Kit that contains 1 tranceiver, 1 clinical probe, 1 speaker Dock, and 1 pack of ultrasound gel
Surgical Configuration
A separate surgical probe is supplied sterile with a sheath that covers the reusable transceiver for use in a sterile field. That configuration also supports specified intraoperative, neurological and transrectal applications. The probe configuration determines the intended use.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Helen of Troy Macao Limited | Macau | Guangdong | Private-label distributor | 11 |
| Dongguan Mars Medical Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 9 |
| Onbo Electronic (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Remington Medical, Inc., United States |
|---|---|
| FDA product code | DPW |
| Device type | Flowmeter, Blood, Cardiovascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K251904 |
| Record published | 2025-11-27 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Sizes | Length 290.8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VC-KIT-02 | Length 290.8 mm | In distribution |
| VC-KIT-01 | Length 290.8 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transonic | Transonic Systems, Inc. | 627 |
| SonoTT Vascular Probe | Em-Tec GmbH | 12 |
| BiDop 7 probe | Koven Technology, Inc. | 8 |
| Medistim MiraQ Cardiac System | Medistim ASA | 6 |
| Medistim MiraQ Vascular System | Medistim ASA | 6 |
| FlowMet™ | Medtronic, Inc. | 4 |
| GEM Flow Coupler | Synovis Micro Companies Alliance | 4 |
| CooperSurgical® | Coopersurgical, Inc. | 4 |
| Medistim System Activation Card | Medistim ASA | 3 |
| 811-BL 24V Foreign & Domestic | Parks Medical Electronics, Inc. | 3 |
| Medistim MiraQ Ultimate System | Medistim ASA | 3 |
| Dopplex | Huntleigh Healthcare Ltd. | 3 |
Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251904 | 2025-11-20 |
| K241583 | 2024-08-30 |
| K211589 | 2022-01-27 |
| K212065 | 2021-10-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.