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Santreva-ATK

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref AS-1963-02Model AS-2099510(k) K252315

by Angiosafe Inc

Identity

Trade Name
Santreva-ATK EUDAMED
Device Name
Santreva-ATK Endovascular Revascularization Catheter EUDAMED
Model / Reference
AS-2099 EUDAMED
AS-1963-02 EUDAMED

Identifiers

Primary DI / UDI-DI
00860009199705 EUDAMED
Basic UDI-DI
08600091997PER2R8 EUDAMED
510(k) Number
K252315 FDA 510(k)
FDA Product Code
PDU FDA 510(k)
EMDN Code
C0104020209 PERIPHERAL VASCULAR SYSTEM TOTAL CHRONIC OCCLUSION DEVICES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Market of Registration
Italy EUDAMED
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Santreva-ATK by AngioSafe, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Angiosafe Inc
EUDAMED SRN
US-MF-000047926
Authorised Representative
OMC NI MEDICAL LIMITED XI-AR-000019483

Sources (2)

  • EUDAMED 7d2b3ddd-9c35-4aba-9f10-58d36796c80d 61 fields · synced Jul 19, 2026
  • FDA 510(k) K252315 24 fields · synced May 18, 2026