FDA.reportPublic FDA data

Armada

Primary DI
08717648156120
Brand
Armada
Company
ABBOTT VASCULAR INC.
Model
A2040-020
Catalog number
A2040-020
Device description
Armada 14 PTA Catheter 4.0 mm x 20 mm x 150 cm / Over-The-Wire
Published
2016-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717648156120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648156120087176481561208717648156120

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, 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; 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. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry. Keep away from sunlight. Temperature limitation 59 deg. F to 86 deg. F (15 deg. C to 30 deg. C)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags#

DUNS number
964569052
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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
08717648353765Esprit™Esprit™1212375-282025-07-12
08717648353666Esprit™Esprit™1212350-182025-07-10
08717648353680Esprit™Esprit™1212350-282025-07-10
08717648353703Esprit™Esprit™1212350-382025-07-10
08717648353741Esprit™Esprit™ 1212375-182025-07-10
08717648353789Esprit™Esprit™1212375-382025-07-10
08717648353826Esprit™Esprit™1212250-182025-07-10
08717648353840Esprit™Esprit™1212250-282025-07-10
08717648353864Esprit™Esprit™1212250-382025-07-10
08717648353987Esprit™Esprit™1212300-182025-07-10
08717648354007Esprit™Esprit™1212300-282025-07-10
08717648354021Esprit™Esprit™1212300-382025-07-10
08717648356704XACT™83024-0183024-012025-04-17
08717648356742XACT™ 83022-0183022-012025-04-17
08717648356766XACT™83020-0183020-012025-04-17
08717648356803XACT™83026-0183026-012025-04-17
08717648356810HI-TORQUE COMMAND™ 106000110600012024-11-21
08717648356827HI-TORQUE COMMAND™ 1060001A1060001A2024-11-21
08717648356834HI-TORQUE COMMAND™106000210600022024-11-21
08717648356841HI-TORQUE COMMAND™ 1060002A1060002A2024-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640119558639Passeo-18Biotronik AGLIT2016-08-24
07640119558646Passeo-18Biotronik AGLIT2016-08-24
07640119558653Passeo-18Biotronik AGLIT2016-08-24
07640119558660Passeo-18Biotronik AGLIT2016-08-24
07640119558677Passeo-18Biotronik AGLIT2016-08-24
07640119558684Passeo-18Biotronik AGLIT2016-08-24
07640119558691Passeo-18Biotronik AGLIT2016-08-24
07640119558707Passeo-18Biotronik AGLIT2016-08-24
07640119558714Passeo-18Biotronik AGLIT2016-08-24
07640119558721Passeo-18Biotronik AGLIT2016-08-24
07640119558738Passeo-18Biotronik AGLIT2016-08-24
07640119558745Passeo-18Biotronik AGLIT2016-08-24
07640119558752Passeo-18Biotronik AGLIT2016-08-24
07640119558769Passeo-18Biotronik AGLIT2016-08-24
07640119558776Passeo-18Biotronik AGLIT2016-08-24
07640119558783Passeo-18Biotronik AGLIT2016-08-24
07640119558790Passeo-18Biotronik AGLIT2016-08-24
07640119558806Passeo-18Biotronik AGLIT2016-08-24
07640119558813Passeo-18Biotronik AGLIT2016-08-24
07640119558820Passeo-18Biotronik AGLIT2016-08-24
07640119558837Passeo-18Biotronik AGLIT2016-08-24
07640119558844Passeo-18Biotronik AGLIT2016-08-24
07640119558851Passeo-18Biotronik AGLIT2016-08-24
07640119558868Passeo-18Biotronik AGLIT2016-08-24
07640119558875Passeo-18Biotronik AGLIT2016-08-24
07640119558882Passeo-18Biotronik AGLIT2016-08-24
07640119558899Passeo-18Biotronik AGLIT2016-08-24
07640119558905Passeo-18Biotronik AGLIT2016-08-24
07640119558912Passeo-18Biotronik AGLIT2016-08-24
07640119558929Passeo-18Biotronik AGLIT2016-08-24