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 - Cardiovascular Systems Inc.

Address:

1225 Old Highway 8 NW

Saint Paul

Minnesota 55112

United States

Authorised Representative/ UK Responsible Person
Name: ICON (LR) Limited
Address:

Concept House 6 Stoneycroft Rise

Chandlers Ford Eastleigh

Hampshire

SO53 3LD

England United Kingdom

Code/Term Type

Mechanical atherectomy system coronary line-powered Mechanical atherectomy system coronary line-powered Class III

Mechanical atherectomy system catheter peripheral Mechanical atherectomy system catheter peripheral Class IIb

Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Class IIb

Atherectomy system lubricant Atherectomy system lubricant Class IIa

Peripheral vascular guidewire manual Peripheral vascular guidewire manual Class IIa

Cardiac/peripheral vascular guidewire single-use Cardiac/peripheral vascular guidewire single-use 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
Mechanical atherectomy system coronary line-powered	Mechanical atherectomy system coronary line-powered	Class III
Mechanical atherectomy system catheter peripheral	Mechanical atherectomy system catheter peripheral	Class IIb
Atherectomy system saline/lubricant pump	Atherectomy system saline/lubricant pump	Class IIb
Atherectomy system lubricant	Atherectomy system lubricant	Class IIa
Peripheral vascular guidewire manual	Peripheral vascular guidewire manual	Class IIa
Cardiac/peripheral vascular guidewire single-use	Cardiac/peripheral vascular guidewire single-use	Class III