Max. value paid with public resources: Processing

Data for med. device

Medical device code

07IIIC1718447970

Form date

18/10/2017 11:39

Record date MD

18/10/2017 17:01

Date introduce requestor in the system

02/12/2016 17:16

Identification of the manufacturer

Manufacturer name, long

Lutonix, Inc.

Code type

Other

Document type

US

Code

US

Country code

US

City

New Hope

Postal code

MN 55428

Contact person

Isabel De La Cal Garcia

Phone

+49 721 9445 463

E-mail

Isabel.DeLaCal@crbard.com

Identification of the person placing the product on the market

Name of the person placing the product on the market

Devimed Ltd.

Code type

EIK

Code

130322047

Country code

BG

Region code

SOF

City

Sofia

Contact person

Aleksandar Madzharov

Phone

029533616

E-mail

devimed@abv.bg

Identification of the wholesaler

Wholesaler name

Devimed Ltd.

Code type

EIK

Code

130322047

Country code

BG

Region code

SOF

City

Sofia

Contact person

Aleksandar Madzharov

Phone

029533616

E-mail

devimed@abv.bg

Number of authorization/certificate for wholesale trade with medical devices

IV-Р-Т/МИ-180

Date of authorization/certificate for wholesale trade with medical devices

10/12/2007

General medical information about the device

Category of the medical device

07 - Non-active implantable devices

Risk clasification

Class ІІІ

Anatomical group

Cardiovascular system

Code type

GMDN

Code value

17184

Name	Lutonix® 014 Drug Coated Balloon PTA Catheter

Intended action by the manufacturer

Purpose

The Lutonix® 014 Drug Coated Balloon Catheter is intended for use as a PTA catheter to dilate stenotic or obstructive vascular lesions in the lower extremities, for the purpose of improving limb perfusion and decreasing the incidence of restenosis.

Usage

Single use

General trade information

Max. value paid with public resources

Processing

CE certificate number

CE 665621

CE certificate expiration date

02/03/2022