Vesoflow Plus DVT Compression Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141064 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5800 FDA 510(k)
- Regulation Number
- 870.5800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vesoflow Plus DVT Compression Device is a Sleeve, Limb, Compressible designed to provide intermittent and sequential pneumatic compression. It is classified as a Class II medical device and functions by counteracting venous stasis and coagulation factors to help prevent deep vein thrombosis (DVT).
This device is intended for use in clinical settings to enhance venous return in at-risk patients, reducing the risk of DVT-related complications. Supplied as a reusable pneumatic system, it requires proper calibration and maintenance as per manufacturer guidelines. Authorised under FDA 510(k) and MDR, it adheres to regulatory standards for cardiovascular devices, with specific compliance to regulation number 870.5800. Multiple model variants are available, each corresponding to distinct limb sizes and compression profiles.
Frequently asked questions
What is the primary purpose of the Vesoflow Plus DVT Compression Device in clinical settings?
The Vesoflow Plus DVT Compression Device is designed to provide intermittent and sequential pneumatic compression to counteract venous stasis and coagulation factors. Its main purpose is to help prevent deep vein thrombosis (DVT) in at-risk patients by enhancing venous return, thereby reducing the risk of DVT-related complications.
Is the Vesoflow Plus DVT Compression Device reusable, and if so, what maintenance is required?
Yes, the Vesoflow Plus DVT Compression Device is supplied as a reusable pneumatic system. It requires proper calibration and maintenance as outlined by the manufacturer to ensure safe and effective operation. Regular upkeep is essential to sustain performance and compliance with regulatory standards.
How many model variants are available, and what do they account for?
Multiple model variants of the Vesoflow Plus DVT Compression Device are available, each tailored to distinct limb sizes and compression profiles. This variety ensures compatibility with different patient anatomies and clinical needs, allowing for customized treatment.
What regulatory approvals does the Vesoflow Plus DVT Compression Device hold, and how does this affect its use?
The device is authorized under both FDA 510(k) and MDR (Medical Device Regulation) pathways, indicating compliance with U.S. and European regulatory standards. These approvals confirm that the device meets established safety and performance criteria for cardiovascular devices, specifically under regulation number 870.5800, ensuring its legitimacy for clinical use.
Are there specific storage instructions or considerations for the Vesoflow Plus DVT Compression Device?
While the provided data does not explicitly detail storage instructions, as a reusable pneumatic device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling and storage are critical to maintaining the integrity of the device and ensuring longevity, particularly since it requires calibration and maintenance.
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: DVT - Caremed Supply, Inc., VESOFLOW PLUS DVT COMPRESSION DEVICE (K141064) — FDA 510(k) | Innolitics, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ..., VESOFLOW (K110977) — FDA 510 (k) | Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141064 | Class II | Active |
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Manufacturer
- Manufacturer
- Caremed Supply, Inc.
Sources (2)
- FDA 510(k) K141064 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026