Vasoview Hemopro 3 Power Supply

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K243918Ref VH-6010Model Vasoview Hemopro Power Supply

by Maquet Cardiovascular LLC

Identity

Trade Name: Vasoview Hemopro 3 Power Supply EUDAMED
VASOVIEW HEMOPRO 3 FDA UDI
Generic Name: Basic power supply, reusable FDA UDI
Device Name: The Vasoview Hemopro 3 Power Supply is a reusable, AC-powered device intended to be used only with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System. The device provides DC power output to the Vasoview Hemopro 3 Harvesting Tool to enable cutting and coagulation of vessels and tissue during vessel harvesting procedures. The Vasoview Hemopro 3 Power Supply is positioned outside the sterile field, and can be placed on a flat, non-sterile surface or may be suspended from a nearby IV pole. The Vasoview Hemopro 3 Power Supply does not make contact with the patient, nor does it deliver energy directly to the patient; energy to the patient is delivered by the Hemopro 3 Harvesting Tool. The Hemopro 3 Power Supply is intended to be used by healthcare professionals in an operating room environment. FDA UDI
Model / Reference: VH-6010 EUDAMEDFDA UDI
Vasoview Hemopro Power Supply EUDAMED
Description: The Vasoview Hemopro 3 Power Supply is a reusable, AC-powered device intended to be used only with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System. The device provides DC power output to the Vasoview Hemopro 3 Harvesting Tool to enable cutting and coagulation of vessels and tissue during vessel harvesting procedures. The Vasoview Hemopro 3 Power Supply is positioned outside the sterile field, and can be placed on a flat, non-sterile surface or may be suspended from a nearby IV pole. The Vasoview Hemopro 3 Power Supply does not make contact with the patient, nor does it deliver energy directly to the patient; energy to the patient is delivered by the Hemopro 3 Harvesting Tool. The Hemopro 3 Power Supply is intended to be used by healthcare professionals in an operating room environment. FDA UDI

Identifiers

Catalog Number: VH-6010 FDA UDI
Primary DI / UDI-DI: 00607567701281 EUDAMEDFDA UDI
Basic UDI-DI: 607567VH-3010TA EUDAMED
510(k) Number: K243918 FDA 510(k)
K251238 FDA UDI
FDA Product Code: GEI FDA 510(k)FDA UDI
EMDN Code: L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term: Basic power supply, reusable FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 878.4400 FDA 510(k)
Regulation Number: 878.4400 FDA 510(k)FDA UDI
Market of Registration: Netherlands EUDAMED
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Vasoview Hemopro 3 Power Supply is a medical electrical device designed for powering and controlling extracorporeal circulation systems, specifically within cardiopulmonary bypass and related perfusion procedures. It provides regulated electrical output to drive pumps and other components in these critical surgical applications, ensuring precise hemodynamic support during procedures requiring temporary circulatory assistance.

This device is supplied as a reusable, non-sterile unit intended for use in controlled clinical environments such as operating rooms and cardiac catheterization labs. It is classified under product code GEI (General and Plastic Surgery Devices) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. Compliance with MDR (Medical Device Regulation) standards is also noted, with specifications tailored for integration with perfusion systems in cardiac and vascular surgeries.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K243918	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Maquet Cardiovascular LLC
FDA Applicant: Maquet Cardiovascular, LLC

Sources (3)

FDA 510(k) K243918 24 fields · synced Sep 18, 2026
FDA UDI fde7c5c5-a9f1-4acb-8860-30c4853e6c37 36 fields · synced May 29, 2026
EUDAMED 9b8569f9-7f89-4df5-8c11-7918128d2dae 61 fields · synced Jul 15, 2026