Spectranetics Corporation

Address:6655 Wedgwood Road North,Maple Grove,MN,55311,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, Peripheral, Atherectomy (MCW) (10)

Premarket Exempt

Clear

Turbo-Elite™ - 00813132020101 Catalog Number : 410-154

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo-Elite™ - 00813132020118 Catalog Number : 414-151

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo-Elite™ - 00813132020125 Catalog Number : 414-159

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo-Elite™ - 00813132020132 Catalog Number : 417-152

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo-Elite™ - 00813132020149 Catalog Number : 417-156

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo-Elite™ - 00813132020156 Catalog Number : 420-006

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo-Elite™ - 00813132020163 Catalog Number : 420-159

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo-Elite™ - 00813132020170 Catalog Number : 423-001

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo-Elite™ - 00813132020187 Catalog Number : 425-011

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo Elite™ - 00813132020194 Catalog Number : 423-135-01

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

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