Spectranetics Corporation

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, Angioplasty, Laser, Coronary (LPC) (9) Catheter, Peripheral, Atherectomy (MCW) (1)

Premarket Exempt

No

Clear

ELCA™ - 00813132020002 Catalog Number : 110-001

Device Description : ELCA™ Coronary Laser Atherectomy Catheter

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

ELCA™ - 00813132020019 Catalog Number : 110-002

Device Description : ELCA™ Coronary Laser Atherectomy Catheter

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

ELCA™ - 00813132020026 Catalog Number : 110-003

Device Description : ELCA™ Coronary Laser Atherectomy Catheter

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

ELCA™ - 00813132020033 Catalog Number : 110-004

Device Description : ELCA™ Coronary Laser Atherectomy Catheter

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

ELCA™ - 00813132020040 Catalog Number : 114-009

Device Description : ELCA™ Coronary Laser Atherectomy Catheter

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

ELCA™ - 00813132020057 Catalog Number : 117-016

Device Description : ELCA™ Coronary Laser Atherectomy Catheter

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

ELCA™ - 00813132020064 Catalog Number : 117-205

Device Description : ELCA™ Coronary Laser Atherectomy Catheter

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

ELCA™ - 00813132020071 Catalog Number : 120-008

Device Description : ELCA™ Coronary Laser Atherectomy Catheter

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

ELCA™ - 00813132020088 Catalog Number : 120-009

Device Description : ELCA™ Coronary Laser Atherectomy Catheter

Device Class : 3

Duns Number: 151047370

Premarket Exempt : No

Product Code : LPC

Prescription Use : Yes

Device Count : 1

Turbo-Elite™ - 00813132020095 Catalog Number : 410-152

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

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