FDA.reportPublic FDA data

Ranger™

Primary DI
00191506065669
Brand
Ranger™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939501400810
Catalog number
H74939501400810
Device description
Paclitaxel-Coated PTA Balloon Catheter
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
P190019043

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190019043Ranger™ Paclitaxel-Coated PTA Balloon CatheterBoston Scientific Corporation2020-10-30ONU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506065669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506065669001915060656691915060656690191506065669

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 Diameter0
Balloon Length0
Catheter Length0

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526625008ACUITY™706070602026-10-15
08714729748861RX Cholangiogram KitM005711502016-09-24
08714729748878RX Cholangiogram KitM005711602016-09-24
08714729749097RX Cholangiogram KitM005714002016-09-24
08714729749110RX Cholangiogram KitM005714202016-09-24
08714729749257RX Cholangiogram KitM005715602016-09-24
08714729749295RX Cholangiogram KitM005716002016-09-24
08714729749332RX Cholangiogram KitM005716402016-09-24
08714729749394RX Cholangiogram KitM005717002016-09-24
08714729749509RX Cholangiogram KitM005718102016-09-24
08714729749615RX Cholangiogram KitM005719202016-09-24
00191506065577Ranger™H74939501400470H749395014004702026-10-14
00191506065584Ranger™H74939501400670H749395014006702026-10-14
00191506065591Ranger™H74939501400870H749395014008702026-10-14
00191506065607Ranger™H74939501401070H749395014010702026-10-14
00191506065614Ranger™H74939501401270H749395014012702026-10-14
00191506065621Ranger™H74939501401570H749395014015702026-10-14
00191506065638Ranger™H74939501402070H749395014020702026-10-14
00191506065645Ranger™H74939501400410H749395014004102026-10-14
00191506065652Ranger™H74939501400610H749395014006102026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506065577Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065584Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065591Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065607Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065614Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065621Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065638Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065645Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065652Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065676Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065683Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065690Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065706Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065713Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065720Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065737Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065744Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065751Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065768Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065775Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065782Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065799Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065805Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065812Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065829Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065836Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065843Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065850Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065867Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065874Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14