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

Device, Removal, Pacemaker Electrode, Percutaneous (MFA) (5) Catheter, Peripheral, Atherectomy (MCW) (3) Catheter For Crossing Total Occlusions (PDU) (2)

Premarket Exempt

Clear

Turbo Elite™ - 00813132020217 Catalog Number : 425-135-01

Device Description : Turbo-Elite™ Laser Atherectomy Catheter

Device Class :

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo Tandem™ - 00813132020231 Catalog Number : 472-110

Device Description : Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo Tandem™ - 00813132020255 Catalog Number : 482-110

Device Description : Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Turbo-Booster™ - 00813132020279 Catalog Number : 518-043

Device Description : Turbo-Booster™ Laser Guide Catheter

Device Class :

Duns Number: 151047370

Premarket Exempt : No

Product Code : PDU

Prescription Use : Yes

Device Count : 1

Turbo-Booster™ - 00813132020286 Catalog Number : 518-063

Device Description : Turbo-Booster™ Laser Guide Catheter

Device Class :

Duns Number: 151047370

Premarket Exempt : No

Product Code : PDU

Prescription Use : Yes

Device Count : 1

SLS™II - 00813132020293 Catalog Number : 500-001

Device Description : SLS™II Laser Sheath

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : MFA

Prescription Use : Yes

Device Count : 1

SLS™II - 00813132020309 Catalog Number : 500-012

Device Description : SLS™II Laser Sheath

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : MFA

Prescription Use : Yes

Device Count : 1

SLS™II - 00813132020316 Catalog Number : 500-013

Device Description : SLS™II Laser Sheath

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : MFA

Prescription Use : Yes

Device Count : 1

GlideLight™ - 00813132020323 Catalog Number : 500-301

Device Description : GlideLight™ Laser Sheath

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : MFA

Prescription Use : Yes

Device Count : 1

GlideLight™ - 00813132020330 Catalog Number : 500-302

Device Description : GlideLight™ Laser Sheath

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : MFA

Prescription Use : Yes

Device Count : 1

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