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Stellarex 0.035" OTW drug-coated angioplasty balloon

FDA UDI

Class III (US FDA UDI)

by Philips Image Guided Therapy Corporation

Identity

Trade Name
Stellarex 0.035" OTW drug-coated angioplasty balloon FDA UDI
Generic Name
Peripheral angioplasty balloon catheter, drug-coated FDA UDI
Device Name
5mm x 100mm x 80cm FDA UDI
Model / Reference
AB35SX050100080 FDA UDI
Description
5mm x 100mm x 80cm FDA UDI

Identifiers

Catalog Number
AB35SX050100080 FDA UDI
Primary DI / UDI-DI
00810060550212 FDA UDI
PMA Number
P160049 FDA UDI
FDA Product Code
ONU FDA UDI
GMDN Term
Peripheral angioplasty balloon catheter, drug-coated FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Balloon Diameter — 5 Millimeter FDA UDI
Balloon Length — 100 Millimeter FDA UDI
Catheter Length — 80 Centimeter FDA UDI

Category: Peripheral angioplasty balloon catheter, drug-coated

Stellarex 0.035" OTW drug-coated angioplasty balloon by Philips Image Guided Therapy Corporation — Class III — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Peripheral angioplasty balloon catheter, drug-coated.

Cleared under the same submission

P160049 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Image Guided Therapy Corporation

Sources (1)

  • FDA UDI 5973b24f-ffb6-4e3e-bf7f-bc956019ec0e 38 fields · synced Jun 9, 2026