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Spur

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref BSPUR460135CEModel BSPUR510(k) DEN240048Ref BSPUR365150CE

by Reflow Medical, Inc.

Identity

Trade Name
Spur EUDAMED
Device Name
Spur EUDAMED
Model / Reference
BSPUR EUDAMED
BSPUR460135CE EUDAMED
BSPUR365150CE EUDAMED

Identifiers

Primary DI / UDI-DI
00850025525183 EUDAMED
00850025525268 EUDAMED
Basic UDI-DI
0850025525BSPURTX EUDAMED
510(k) Number
DEN240048 FDA 510(k)
FDA Product Code
SEU FDA 510(k)
EMDN Code
C010402020699 PERIPHERAL ATHERECTOMY SYSTEMS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5110 FDA 510(k)
Regulation Number
870.5110 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
DENG 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

Spur by Reflow Medical, 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
Reflow Medical, Inc.
EUDAMED SRN
US-MF-000017521
Authorised Representative
MediMark Europe Sarl. FR-AR-000000182

Sources (3)

  • EUDAMED e594e20d-1398-4066-bfd6-d7851feb89d7 61 fields · synced Oct 6, 2026
  • FDA 510(k) DEN240048 24 fields · synced May 18, 2026
  • EUDAMED 162066ca-8b6f-4078-886f-da5ff7e6dd19 61 fields · synced Jul 10, 2026