Advocate

Primary DI
05397132010812
Brand
Advocate
Company
ARRAVASC LIMITED
Model
A14040020150
Device description
Advocate 0.014” (4.0mm x 20mm x 1500mm)
Published
2018-03-01
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
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162316000Pirouette 014Arravasc, Ltd.2016-11-22LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05397132010812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05397132010812053971320108125397132010812

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 microsurgical blades (atherotomes) to score the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
896165250
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05397132005528AdvocateA180400400452016-08-02
05397132005535AdvocateA180400600452016-09-07
05397132005542AdvocateA180500400452016-09-01
05397132005559AdvocateA180500600452016-09-01
05397132005566AdvocateA180600400452016-09-01
05397132005573AdvocateA180600600452016-09-01
05397132005580AdvocateA180700400452016-09-01
05397132005597AdvocateA180700600452016-09-01
05397132005603AdvocateA180200600902016-09-01
05397132005610AdvocateA180200800902016-09-01
05397132005627AdvocateA180201000902016-09-01
05397132005634AdvocateA180250600902016-09-01
05397132005641AdvocateA180250800902016-09-01
05397132005658AdvocateA180251000902016-09-01
05397132005665AdvocateA180300400902016-09-01
05397132005672AdvocateA180300600902016-09-01
05397132005689AdvocateA180300800902016-09-01
05397132005696AdvocateA180301000902016-09-01
05397132005702AdvocateA180301500902016-09-01
05397132005719AdvocateA180302000902016-09-01

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Primary DI, Brand, Company table
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