FDA.reportPublic FDA data

Victory 0.014" PTA OTW Catheter

Primary DI
06091403557608
Brand
Victory 0.014" PTA OTW Catheter
Company
NATEC MEDICAL LTD
Model
VAC053_00-100US
Device description
Victory 0.014" PTA OTW Catheter, 3.00 X 100 MM/ Shaft length 150 CM
Published
2025-03-17
Public version status
New
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
06091403557608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06091403557608060914035576086091403557608

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter3Millimeter
Balloon Length100Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep dry and keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+2304663054info@natec-medical.com

Regulatory Flags#

DUNS number
565545733
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
06091403562626Amethyst HP PTA OTW 0.035" catheterPJ0804_00-40S2026-01-29
06091403562633Amethyst HP PTA OTW 0.035" catheterPJ0804_00-60S2026-01-29
06091403562640Amethyst HP PTA OTW 0.035" catheterPJ0804_00-80S2026-01-29
06091403562657Amethyst HP PTA OTW 0.035" catheterPJ0804_00-100S2026-01-29
06091403562664Amethyst HP PTA OTW 0.035" catheterPJ0805_00-20S2026-01-29
06091403562671Amethyst HP PTA OTW 0.035" catheterPJ0805_00-40S2026-01-29
06091403562688Amethyst HP PTA OTW 0.035" catheterPJ0805_00-60S2026-01-29
06091403562695Amethyst HP PTA OTW 0.035" catheterPJ0805_00-80S2026-01-29
06091403562701Amethyst HP PTA OTW 0.035" catheterPJ0805_00-100S2026-01-29
06091403562718Amethyst HP PTA OTW 0.035" catheterPJ0806_00-20S2026-01-29
06091403562725Amethyst HP PTA OTW 0.035" catheterPJ0806_00-40S2026-01-29
06091403562732Amethyst HP PTA OTW 0.035" catheterPJ0806_00-60S2026-01-29
06091403562749Amethyst HP PTA OTW 0.035" catheterPJ0806_00-80S2026-01-29
06091403562756Amethyst HP PTA OTW 0.035" catheterPJ0806_00-100S2026-01-29
06091403562763Amethyst HP PTA OTW 0.035" catheterPJ0812_00-20S2026-01-29
06091403562770Amethyst HP PTA OTW 0.035" catheterPJ0812_00-40S2026-01-29
06091403562787Amethyst HP PTA OTW 0.035" catheterPH0804_00-20S2026-01-29
06091403562794Amethyst HP PTA OTW 0.035" catheterPH0804_00-40S2026-01-29
06091403562800Amethyst HP PTA OTW 0.035" catheterPH0804_00-60S2026-01-29
06091403562817Amethyst HP PTA OTW 0.035" catheterPH0804_00-80S2026-01-29

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