FDA.report

Empira™ RX PTCA Dilatation Catheter

Primary DI
00812917020374
Brand
Empira™ RX PTCA Dilatation Catheter
Company
TACTX MEDICAL, INC.
Model
85R15350S
Catalog number
85R15350S
Device description
Empira™ 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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812917020374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812917020374008129170203748129170203740812917020374

GMDN Terms

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

TypeValueUnit
Outer Diameter3.5Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
363487070
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
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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