FDA.reportPublic FDA data

Empira™ NC RX PTCA Dilatation Catheter

Primary DI
00812917020961
Brand
Empira™ NC RX PTCA Dilatation Catheter
Company
TACTX MEDICAL, INC.
Model
75R12400N
Catalog number
75R12400N
Device description
Empira™ NC RX PTCA Dilatation Catheter
Published
2016-09-23
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
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
00812917020961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812917020961008129170209618129170209610812917020961

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
Length12Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
363487070
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812917020008Empira™ RX PTCA Dilatation Catheter85R06150S85R06150S2016-09-23
00812917020015Empira™ RX PTCA Dilatation Catheter85R06200S85R06200S2016-09-23
00812917020022Empira™ RX PTCA Dilatation Catheter85R06225S85R06225S2016-09-23
00812917020039Empira™ RX PTCA Dilatation Catheter85R06250S85R06250S2016-09-23
00812917020046Empira™ RX PTCA Dilatation Catheter85R06275S85R06275S2016-09-23
00812917020053Empira™ RX PTCA Dilatation Catheter85R06300S85R06300S2016-09-23
00812917020060Empira™ RX PTCA Dilatation Catheter85R06325S85R06325S2016-09-23
00812917020077Empira™ RX PTCA Dilatation Catheter85R06350S85R06350S2016-09-23
00812917020084Empira™ RX PTCA Dilatation Catheter85R06375S85R06375S2016-09-23
00812917020091Empira™ RX PTCA Dilatation Catheter85R06400S85R06400S2016-09-23
00812917020107Empira™ RX PTCA Dilatation Catheter85R10150S85R10150S2016-09-23
00812917020114Empira™ RX PTCA Dilatation Catheter85R10200S85R10200S2016-09-23
00812917020121Empira™ RX PTCA Dilatation Catheter85R10225S85R10225S2016-09-23
00812917020138Empira™ RX PTCA Dilatation Catheter85R10250S85R10250S2016-09-23
00812917020145Empira™ RX PTCA Dilatation Catheter85R10275S85R10275S2016-09-23
00812917020152Empira™ RX PTCA Dilatation Catheter85R10300S85R10300S2016-09-23
00812917020169Empira™ RX PTCA Dilatation Catheter85R10325S85R10325S2016-09-23
00812917020176Empira™ RX PTCA Dilatation Catheter85R10350S85R10350S2016-09-23
00812917020183Empira™ RX PTCA Dilatation Catheter85R10375S85R10375S2016-09-23
00812917020190Empira™ RX PTCA Dilatation Catheter85R10400S85R10400S2016-09-23

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Primary DI, Brand, Company table
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