FDA.reportPublic FDA data

Stellarex

Primary DI
00813132028787
Brand
Stellarex
Company
Philips Image Guided Therapy Corporation
Model
AB35SX040100080
Catalog number
AB35SX040100080
Device description
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 100mm) x 80cm
Published
2022-01-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONUDrug-Eluting Peripheral Transluminal Angioplasty CatheterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160049012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160049012STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONThe Spectranetics Corp.2017-07-26ONU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813132028787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813132028787008131320287878131320287870813132028787

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, drug-coatedA sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter4Millimeter
Balloon Length100Millimeter
Balloon Proximal Outer Diamete4Millimeter
Catheter Length80Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Keep dry; keep away from sunlight
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-231-0978SPNC-complaints@philips.com

Regulatory Flags#

DUNS number
118354223
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225012939IntraSight Plus7974177974172026-05-26
00845225012946IntraSight Plus7974237974232026-05-26
00813132028824StellarexAB35SX040040080AB35SX0400400802022-01-05
00813132028763StellarexAB35SX060100135AB35SX0601001352022-01-13
00813132028770StellarexAB35SX040100135AB35SX0401001352022-01-13
00813132028794StellarexAB35SX050100080AB35SX0501000802022-01-13
00813132028800StellarexAB35SX060100080AB35SX0601000802022-01-13
00813132028817StellarexAB35SX050100135AB35SX0501001352022-01-13
00813132028831StellarexAB35SX040080080AB35SX0400800802022-01-13
00813132028848StellarexAB35SX040120080AB35SX0401200802022-01-13
00813132028855StellarexAB35SX050040080AB35SX0500400802022-01-13
00813132028862StellarexAB35SX050080080AB35SX0500800802022-01-13
00813132028879StellarexAB35SX050120080AB35SX0501200802022-01-13
00813132028886StellarexAB35SX060040080AB35SX0600400802022-01-13
00813132028893StellarexAB35SX060080080AB35SX0600800802022-01-13
00813132028909StellarexAB35SX060120080AB35SX0601200802022-01-13
00813132028916StellarexAB35SX040040135AB35SX0400401352022-01-13
00813132028923StellarexAB35SX040080135AB35SX0400801352022-01-13
00813132028930StellarexAB35SX040120135AB35SX0401201352022-01-13
00813132028947StellarexAB35SX050040135AB35SX0500401352022-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150001811IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001828IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001842IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001859IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001873IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001880IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001903IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001910IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001934IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001941IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001965IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001972IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00191506046613Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046620Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046637Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046644Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046651Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046668Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046675Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046682Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046699Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046705Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046712Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046729Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046736Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046743Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046750Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046767Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046774Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046781Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05