FDA.reportPublic FDA data

FILAO NC PTCA Dilatation Catheter

Primary DI
06091403517800
Brand
FILAO NC PTCA Dilatation Catheter
Company
NATEC MEDICAL LTD
Model
N022_00-30US
Device description
FILAO NC PTCA Dilatation Catheter, 2.00 X 30 MM/ Shaft length 140 CM
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06091403517800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06091403517800060914035178006091403517800

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter2Millimeter
Balloon Length30Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep dry and keep away from sunlight and humidity.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
565545733
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06091403562626"Amethyst HP PTA OTW 0.035"" catheter"PJ0804_00-40S2026-01-29
06091403562633"Amethyst HP PTA OTW 0.035"" catheter"PJ0804_00-60S2026-01-29
06091403562640"Amethyst HP PTA OTW 0.035"" catheter"PJ0804_00-80S2026-01-29
06091403562657"Amethyst HP PTA OTW 0.035"" catheter"PJ0804_00-100S2026-01-29
06091403562664"Amethyst HP PTA OTW 0.035"" catheter"PJ0805_00-20S2026-01-29
06091403562671"Amethyst HP PTA OTW 0.035"" catheter"PJ0805_00-40S2026-01-29
06091403562688"Amethyst HP PTA OTW 0.035"" catheter"PJ0805_00-60S2026-01-29
06091403562695"Amethyst HP PTA OTW 0.035"" catheter"PJ0805_00-80S2026-01-29
06091403562701"Amethyst HP PTA OTW 0.035"" catheter"PJ0805_00-100S2026-01-29
06091403562718"Amethyst HP PTA OTW 0.035"" catheter"PJ0806_00-20S2026-01-29
06091403562725"Amethyst HP PTA OTW 0.035"" catheter"PJ0806_00-40S2026-01-29
06091403562732"Amethyst HP PTA OTW 0.035"" catheter"PJ0806_00-60S2026-01-29
06091403562749"Amethyst HP PTA OTW 0.035"" catheter"PJ0806_00-80S2026-01-29
06091403562756"Amethyst HP PTA OTW 0.035"" catheter"PJ0806_00-100S2026-01-29
06091403562763"Amethyst HP PTA OTW 0.035"" catheter"PJ0812_00-20S2026-01-29
06091403562770"Amethyst HP PTA OTW 0.035"" catheter"PJ0812_00-40S2026-01-29
06091403562787"Amethyst HP PTA OTW 0.035"" catheter"PH0804_00-20S2026-01-29
06091403562794"Amethyst HP PTA OTW 0.035"" catheter"PH0804_00-40S2026-01-29
06091403562800"Amethyst HP PTA OTW 0.035"" catheter"PH0804_00-60S2026-01-29
06091403562817"Amethyst HP PTA OTW 0.035"" catheter"PH0804_00-80S2026-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810219610071FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610088FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610095FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610101FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610118FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
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06971591769123Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769130Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769147Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
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