Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Lutonix Inc

Address:

1625 West 3rd Street

Tempe

Arizona 85281

United States

Authorised Representative/ UK Responsible Person
Name: Becton Dickinson U.K. Limited
Address:

1030 Eskdale Road Winnersh Triangle Wokingham

Winnersh

RG41 5TS

England United Kingdom

Code/Term Type

Coronary angioplasty balloon catheter drug-coated Coronary angioplasty balloon catheter drug-coated Class III

Peripheral angioplasty balloon catheter drug-coated Peripheral angioplasty balloon catheter drug-coated Class III

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Coronary angioplasty balloon catheter drug-coated	Coronary angioplasty balloon catheter drug-coated	Class III
Peripheral angioplasty balloon catheter drug-coated	Peripheral angioplasty balloon catheter drug-coated	Class III