FDA.reportPublic FDA data

Ranger™

Primary DI
08714729975878
Brand
Ranger™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939419401590
Device description
Paclitaxel-Coated PTA Balloon Catheter
Published
2020-11-09
Public version status
Update
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
P190019000
P190019003
P190019018

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190019000Ranger™ Paclitaxel-Coated PTA Balloon CatheterBoston Scientific Corporation2020-10-30ONU
P190019003Ranger™ Paclitaxel-Coated PTA Balloon CatheterBoston Scientific Corporation2020-10-30ONU
P190019018Ranger™ Paclitaxel-Coated PTA Balloon CatheterBoston Scientific Corporation2020-10-30ONU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729975878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729975878087147299758788714729975878

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 Length150Millimeter
Catheter Length90Centimeter

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
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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