Spectranetics Corporation

Address:9965 Federal Drive,Colorado Springs,CO,80921,US

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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

Catheter, Percutaneous, Cutting/Scoring (PNO) (7) Device, Angioplasty, Laser, Coronary (LPC) (3)

Premarket Exempt

Clear

CVX-300® - M204CVX3000 Catalog Number : GEN 4.0

Device Description : Excimer Laser System

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

CVX-300®-P - M204CVX300P0 Catalog Number : CVX300P

Device Description : Excimer Laser System

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

CVX-300®-P - M204CVX300PAA0 Catalog Number : CVX300P

Device Description : Excimer Laser System

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

AngioSculpt® - M3702015602014 Catalog Number : 2105-6020

Device Description : AngioSculpt® PTA Scoring Balloon Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : PNO

Prescription Use : Yes

Device Count : 1

AngioSculpt® - M3702039201015 Catalog Number : 2039-2010

Device Description : AngioSculpt® PTA Scoring Balloon Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : PNO

Prescription Use : Yes

Device Count : 1

AngioSculpt® - M3702039202016 Catalog Number : 2039-2020

Device Description : AngioSculpt® PTA Scoring Balloon Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : PNO

Prescription Use : Yes

Device Count : 1

AngioSculpt® - M370203925201 Catalog Number : 2039-2520

Device Description : AngioSculpt® PTA Scoring Balloon Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : PNO

Prescription Use : Yes

Device Count : 1

AngioSculpt® - M3702039302017 Catalog Number : 2039-3020

Device Description : AngioSculpt® PTA Scoring Balloon Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : PNO

Prescription Use : Yes

Device Count : 1

AngioSculpt® - M370203935201 Catalog Number : 2039-3520

Device Description : AngioSculpt® PTA Scoring Balloon Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : PNO

Prescription Use : Yes

Device Count : 1

AngioSculpt® - M3702076402019 Catalog Number : 2076‐4020

Device Description : AngioSculpt® PTA Scoring Balloon Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : PNO

Prescription Use : Yes

Device Count : 1

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