FDA.report

Advocate

Primary DI
05397132006365
Brand
Advocate
Company
ARRAVASC LIMITED
Model
A18035060130
Device description
Advocate 0.018" PTA Catheter (3.5mm x 60mm x 1300mm)
Published
2016-09-07
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

Related Records

Contact Domains

Product Codes

CodeName
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications

CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions

SubmissionSupplement
K151153000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K151153000Pirouette 018Arravasc Limited2015-08-20LIT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05397132006365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05397132006365053971320063655397132006365

GMDN Terms

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

TypeValueUnit
Length60Millimeter
Outer Diameter3.5Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dark, dry, cool place. Avoid extended exposure to light, organic solvents, ionizing radiation or ultraviolet light

Sterilization Methods

Method

Contacts

PhoneEmail
+353091758939cs@arravasc.com

Regulatory Flags

DUNS number
896165250
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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06091403562626Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562633Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562640Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562657Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562664Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562671Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562688Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562695Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562701Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562718Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562725Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562732Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562749Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562756Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562763Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562770Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562787Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562794Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562800Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562817Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562824Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562831Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562848Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562855Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562862Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562879Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562886Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562893Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562909Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562916Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29