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VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar E…

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K191947Ref VH-4030

by Maquet Cardiovascular LLC

Identity

Trade Name
Vasoview Hemopro 2 Extension Cable EUDAMED
HemoPro 2 Extension Cable FDA UDI
Generic Name
Electrical-only medical device connection cable, reusable FDA UDI
Device Name
Vasoview Hemopro 2 Extension Cable EUDAMED
HemoPro 2 Extension Cable FDA UDI
Model / Reference
VH-4030 EUDAMED
C-VH-4030 FDA UDI
Description
HemoPro 2 Extension Cable FDA UDI

Identifiers

Catalog Number
C-VH-4030 FDA UDI
Primary DI / UDI-DI
00607567700925 EUDAMEDFDA UDI
Basic UDI-DI
0607567VH-4030D9 EUDAMED
510(k) Number
K191947 FDA 510(k)
K101274 FDA UDI
FDA Product Code
GEI FDA 510(k)FDA UDI
EMDN Code
K02010203 ELECTROSURGERY CONNECTION CABLES, SINGLE-USE EUDAMED
GMDN Term
Electrical-only medical device connection cable, 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

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

The Vasoview Hemopro Extension Cable is a bipolar extension cable with a fixed distance and active return cord, designed for use with electrocautery systems in surgical procedures. It facilitates precise energy delivery in plastic surgery applications by extending the reach of the active electrode while maintaining a consistent return path for current, reducing interference and improving safety during procedures.

This device is supplied as a single-use, non-sterile extension cable intended for use in controlled surgical environments. It is compatible with MRI-safe systems and is available in a fixed-length configuration to ensure consistent performance. Authorised under FDA 510K and MDR, it is classified under product code GEI and is intended for integration with electrocautery devices in surgical settings.

Frequently asked questions

What types of surgical procedures is this extension cable designed to support, and why is the fixed distance important in those settings?

This extension cable is specifically designed for use in plastic surgery procedures with electrocautery systems. The fixed distance ensures consistent energy delivery and a stable return path for current, which minimizes interference and enhances safety during delicate procedures where precision is critical.

Is this extension cable reusable, or is it intended for single-use only? How does this affect its use in a surgical environment?

The device is explicitly labeled as a single-use extension cable, meaning it is intended for one-time use in controlled surgical settings. This design choice reduces the risk of contamination and cross-infection, which is particularly important in sterile environments like operating rooms.

What length configurations are available for this extension cable, and how does the fixed-length design benefit the user?

The device is supplied in a fixed-length configuration, though the exact length is not specified in the data. The fixed distance ensures reliable performance by maintaining a consistent return path for current, which helps reduce variability in energy delivery during electrocautery procedures.

Is this extension cable compatible with MRI systems, and what does that mean for its use in hybrid or specialized surgical settings?

Yes, the device is explicitly noted as MRI-safe, meaning it can be used in environments where MRI compatibility is required, such as hybrid operating rooms or facilities with integrated imaging systems. This ensures it won’t interfere with MRI procedures or pose risks during concurrent use.

How should this extension cable be stored, and what considerations should be taken into account given its single-use and non-sterile nature?

Since the cable is non-sterile and intended for single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper packaging should remain intact until use to prevent contamination or damage, ensuring it remains ready for sterile surgical environments when needed.

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

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Manufacturer

Manufacturer
Maquet Cardiovascular LLC
FDA Applicant
Maquet Cardiovascular, LLC

Sources (3)

  • FDA 510(k) K191947 24 fields · synced Sep 18, 2026
  • FDA UDI c020ddc7-0677-48ab-82fc-bb5df47d216c 36 fields · synced May 30, 2026
  • EUDAMED c31f74cf-d407-4ffd-b54e-95b2d627e78c 61 fields · synced Jul 19, 2026