Eu Mdd Eu Md Class 3 On The Market 🇪🇸 Spain

ANA Advanced Neurovascular Access™

ANACONDA BIOMED, S.L. · 🇪🇸 Spain
Devices (same UDI-DI)
1
Certificates
2
Countries
1
Notified Bodies
2

Basic Information

Primary DI
D-ANA-1-00001N7
Basic UDI-DI Code
B-ANA-1-00001N7
Reference
1-00001
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market
Manufacturer
ANACONDA BIOMED, S.L.

Additional Description

The ANA Advanced Neurovascular Access™ Device (ANA device or ANA system) is a distal access catheter system designed to assist in neurovascular procedures by facilitating the insertion and guiding of other devices (i.e. retrieval devices and intravascular catheters) and restricting blood flow at the target position. It is a sterile, single use, disposable intravascular device comprised of two coaxial catheters (a delivery catheter and a funnel catheter) consisting of sections with variable stiffness. The funnel catheter is comprised of a radiopaque nitinol braid (a self-expanding funnel) covered by a continuous silicone coating that provides temporary local flow restriction when deployed. The delivery catheter has a hydrophilic coating to reduce friction during use and a radiopaque marker at the distal end. Both catheters have Luer lock hubs on their proximal ends.

CND Nomenclature Codes

Code Description
C01020101 CENTRAL I.V. SINGLE-LUMEN CATHETERS, PERIPHERAL ACCESS

Certificates

Type Number
MDD Annex II (excluding section 4) 2238049CE01
MDD Annex II Section 4 2238049DE01

Available In Countries

🇪🇸 Spain

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