R-One Robotic Platform

Organization name

ROBOCATH S.A.S

SRN

FR-MF-000003651

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW011

  The system should only be used by interventional cardiologists and their staff, who have received specific training for the use of the R-OneTM device. The training provided by Robocath is limited to the use of the system and does not replace the expertise and medical training necessary to perform coronary angioplasty. The movement of the guidewire and/or stent/balloon catheter with the system should not be performed without viewing them using X-rays. The navigation speed of the guidewire and/or stent/balloon catheter should be adapted to the arterial areas traversed. The fast navigation mode should only be used when the guidewire and the stent/balloon catheter are in the guide catheter. The R-OneTM system is not recommended for heavily calcified lesions, ostial lesions, and chronic total occlusions (CTOs). The R-OneTM Robotic Platform is designed to be used exclusively in combination with the Mobile Radioprotection Screen and the R-OneTM Consumable Kit. The R-OneTM system is only compatible with 0.014" guidewires, Rapid exchange stent/balloon catheter, Y connectors: - Super KetchTM by Minvasys - Honor® Hemostasis Valve by Merit Medical. For an optimal use of the system, it is recommended to use a 6 Fr guiding catheter minimum.
• CW273

  The system must only be connected to a power supply with protective earthing. Do not use the system if cables are worn.

Primary placement in France; available across 6 countries total.

Trade name

R-One Robotic Platform

UDI-DI code

D-RBH01P0000RK

Basic UDI-DI

B-RBH01P0000RK

Reference / catalog number

RBH01P0000

Issuing entity

EUDAMED

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12059099VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification