Advocate

Primary DI: 05397132007966
Brand: Advocate
Company: ARRAVASC LIMITED
Model: A35060060130
Device description: Advocate 0.035” PTA Catheter (6.0mm x 60mm x 1300mm)
Published: 2016-09-13
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

arravasc.com

Product Codes

Code	Name
LIT	Catheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications

Code	Device	Specialty	Class
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	2

Premarket Submissions

Submission	Supplement
K161427	000

Premarket Details

Submission	Supplement	Device	Applicant	Decision date	Product code
K161427	000	Pirouette 035	Arravasc Limited	2016-07-30	LIT

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
05397132007966	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
05397132007966	05397132007966	5397132007966

GMDN Terms

Term	Definition
Peripheral angioplasty balloon catheter, basic	A 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.

Term

Definition

Peripheral angioplasty balloon catheter, basic

A 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
Length	60	Millimeter
Outer Diameter	6	Millimeter

Storage And Handling

Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Store in a dark, dry, cool place. Avoid extended exposure to light, organic solvents, ionizing radiation or ultraviolet light

Sterilization Methods

Method

Contacts

Phone	Email
+353091758939	cs@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 DI	Brand	Model	Published
05397132005528	Advocate	A18040040045	2016-08-02
05397132005535	Advocate	A18040060045	2016-09-07
05397132005542	Advocate	A18050040045	2016-09-01
05397132005559	Advocate	A18050060045	2016-09-01
05397132005566	Advocate	A18060040045	2016-09-01
05397132005573	Advocate	A18060060045	2016-09-01
05397132005580	Advocate	A18070040045	2016-09-01
05397132005597	Advocate	A18070060045	2016-09-01
05397132005603	Advocate	A18020060090	2016-09-01
05397132005610	Advocate	A18020080090	2016-09-01
05397132005627	Advocate	A18020100090	2016-09-01
05397132005634	Advocate	A18025060090	2016-09-01
05397132005641	Advocate	A18025080090	2016-09-01
05397132005658	Advocate	A18025100090	2016-09-01
05397132005665	Advocate	A18030040090	2016-09-01
05397132005672	Advocate	A18030060090	2016-09-01
05397132005689	Advocate	A18030080090	2016-09-01
05397132005696	Advocate	A18030100090	2016-09-01
05397132005702	Advocate	A18030150090	2016-09-01
05397132005719	Advocate	A18030200090	2016-09-01

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