FDA.reportPublic FDA data

Ranger™

Primary DI
00191506046736
Brand
Ranger™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939733515020
Catalog number
H74939733515020
Device description
MONORAIL™ Paclitaxel-Coated PTA Balloon Catheter
Published
2025-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
P190019032

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190019032Ranger™ Paclitaxel-Coated PTA Balloon CatheterBoston Scientific Corporation2020-10-30ONU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506046736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506046736001915060467361915060467360191506046736

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 Diameter5Millimeter
Balloon Length150Millimeter
Length200Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24

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
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
00191506046798Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05