FDA.reportPublic FDA data

VASOVIEW HEMOPRO 3

Primary DI
00607567701281
Brand
VASOVIEW HEMOPRO 3
Company
MAQUET CARDIOVASCULAR LLC
Model
VH-6010
Catalog number
VH-6010
Device 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.
Published
2025-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251238000Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)Maquet Cardiovascular, LLC2025-05-30GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607567701281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607567701281006075677012816075677012810607567701281

GMDN Terms#

Term, Definition table
TermDefinition
Basic power supply, reusableA device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-880-2874Customer.Support@maquet.com

Regulatory Flags#

DUNS number
022348156
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384409005546Fusion Vascular GraftsM002015010260M0020150102602015-10-24
00384409005553Fusion Vascular GraftsM002015010410M0020150104102015-10-24
00384409005560Fusion Vascular GraftsM002015010450M0020150104502015-10-24
00384409005577Fusion Vascular GraftsM002015010460M0020150104602015-10-24
00384409005584Fusion Vascular GraftsM002015010470M0020150104702015-10-24
00384409005591Fusion Vascular GraftsM002015010480M0020150104802015-10-24
00384409005607Fusion Vascular GraftsM002015010660M0020150106602015-10-24
00384409005614Fusion Vascular GraftsM002015010680M0020150106802015-10-24
00384409005621Fusion Vascular GraftsM002015010810M0020150108102015-10-24
00384409005638Fusion Vascular GraftsM002015010850M0020150108502015-10-24
00384409005645Fusion Vascular GraftsM002015010860M0020150108602015-10-24
00384409005652Fusion Vascular GraftsM002015010870M0020150108702015-10-24
00384409005669Fusion Vascular GraftsM002015010880M0020150108802015-10-24
00384409005676Fusion Supported Vascular GraftsM002015030410M0020150304102015-10-24
00384409005683Fusion Supported Vascular GraftsM002015030450M0020150304502015-10-24
00384409005690Fusion Supported Vascular GraftsM002015030460M0020150304602015-10-24
00384409005706Fusion Supported Vascular GraftsM002015030470M0020150304702015-10-24
00384409005713Fusion Supported Vascular GraftsM002015030480M0020150304802015-10-24
00607567700376Vasoview EVH Accsessory PackVH-2004VH-20042016-09-24
00607567700772Active Return Cord non-sterileC-1838C-18382016-09-24

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Primary DI, Brand, Company table
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