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® - M370207640401 Catalog Number : 2076‐4040

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® - M370207650201 Catalog Number : 2076‐5020

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® - M370207650401 Catalog Number : 2076‐5040

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® - M370207660201 Catalog Number : 2076‐6020

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® - M370207660401 Catalog Number : 2076‐6040

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® - M3702092404019 Catalog Number : 2092-4040

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® - M370209250401 Catalog Number : 2092-5040

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® - M3702092602019 Catalog Number : 2092-6020

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® - M370209260401 Catalog Number : 2092-6040

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® - M3702105604016 Catalog Number : 2105-6040

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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