Spectranetics Corporation

Address:5055 BRANDIN COURT,FREMONT,CA,94538,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) (10)

Premarket Exempt

Clear

AngioSculpt® - M3702155204017 Catalog Number : 2155-2040

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® - M370215525401 Catalog Number : 2155-2540

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® - M3702155304018 Catalog Number : 2155-3040

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® - M370215535401 Catalog Number : 2155-3540

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® - M37022152010011 Catalog Number : 2215-20100

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® - M37022152510016 Catalog Number : 2215-25100

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® - M37022153010012 Catalog Number : 2215-30100

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® - M37022153510017 Catalog Number : 2215-35100

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® - M37022162010012 Catalog Number : 2216-20100

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® - M37022162510017 Catalog Number : 2216-25100

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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