Stellarex 0.035" OTW Drug-coated Angioplasty Balloon

by Spectranetics Corporation 70 variants

Ref A35SX050060135

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-00813132026226 Basic UDI-DI 00813132026226UDI-DI	Date8 May 2026Registered	StatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Model / Reference: A35SX050060135

Primary DI / UDI-DI: 00813132026226
Basic UDI-DI: B-00813132026226
EMDN Code: C010402020101 PTA balloon dilatation catheters

Device Class: Class III
EU market of registration: Netherlands

Manufacturer details

EUDAMED SRN: US-MF-000020669
Authorised representative: Spectranetics International B.V. NL-AR-000001484

Other devices from Spectranetics Corporation

Lld Ez

Class II
Bridge Occlusion Balloon

Class II
Spectranetics Visisheath Dilator Sheath

Class II
Torqmax Sheath Grip Accessory

Class II
Turbo-Elite Laser Atherectomy Catheter

Class IIa
Tightrail Mini

Class II

See all devices from Spectranetics Corporation →

Properties

Sterile
Administering Medicine
Incorporates Medicinal Product

Other properties (10)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Measuring Function: No