TACTX MEDICAL, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Catheters, Transluminal Coronary Angioplasty, Percutaneous (LOX) (10)

Premarket Exempt

Clear

Empira™ RX PTCA Dilatation Catheter - 00812917020008 Catalog Number : 85R06150S

Device Description : Empira™ RX PTCA Dilatation Catheter

Device Class : 2

Duns Number: 363487070

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

Empira™ RX PTCA Dilatation Catheter - 00812917020015 Catalog Number : 85R06200S

Device Description : Empira™ RX PTCA Dilatation Catheter

Device Class : 2

Duns Number: 363487070

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

Empira™ RX PTCA Dilatation Catheter - 00812917020022 Catalog Number : 85R06225S

Device Description : Empira™ RX PTCA Dilatation Catheter

Device Class : 2

Duns Number: 363487070

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

Empira™ RX PTCA Dilatation Catheter - 00812917020039 Catalog Number : 85R06250S

Device Description : Empira™ RX PTCA Dilatation Catheter

Device Class : 2

Duns Number: 363487070

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

Empira™ RX PTCA Dilatation Catheter - 00812917020046 Catalog Number : 85R06275S

Device Description : Empira™ RX PTCA Dilatation Catheter

Device Class : 2

Duns Number: 363487070

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

Empira™ RX PTCA Dilatation Catheter - 00812917020053 Catalog Number : 85R06300S

Device Description : Empira™ RX PTCA Dilatation Catheter

Device Class : 2

Duns Number: 363487070

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

Empira™ RX PTCA Dilatation Catheter - 00812917020060 Catalog Number : 85R06325S

Device Description : Empira™ RX PTCA Dilatation Catheter

Device Class : 2

Duns Number: 363487070

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

Empira™ RX PTCA Dilatation Catheter - 00812917020077 Catalog Number : 85R06350S

Device Description : Empira™ RX PTCA Dilatation Catheter

Device Class : 2

Duns Number: 363487070

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

Empira™ RX PTCA Dilatation Catheter - 00812917020084 Catalog Number : 85R06375S

Device Description : Empira™ RX PTCA Dilatation Catheter

Device Class : 2

Duns Number: 363487070

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

Empira™ RX PTCA Dilatation Catheter - 00812917020091 Catalog Number : 85R06400S

Device Description : Empira™ RX PTCA Dilatation Catheter

Device Class : 2

Duns Number: 363487070

Premarket Exempt : No

Product Code : LOX

Prescription Use : Yes

Device Count : 1

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