Cardiovascular Systems, Inc.

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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

No Yes

Clear

Diamondback Peripheral - 10850000491011 Catalog Number : 7-10031-10

Device Description : Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Clasic, 145 cm shaft

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Diamondback Peripheral - 10850000491028 Catalog Number : 7-10031-11

Device Description : Diamondback Peripheral, Exchangeable Series, Cartridge, 2.00 Classic, 145 cm shaft

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Diamondback Peripheral - 10850000491035 Catalog Number : 7-10032-01

Device Description : Diamondback Peripheral, Exchangeable Series, Handle Only

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Diamondback Peripheral - 10850000491172 Catalog Number : 7-10057-01

Device Description : DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Diamondback Peripheral - 10850000491189 Catalog Number : 7-10057-02

Device Description : DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Diamondback Peripheral - 10850000491196 Catalog Number : 7-10057-03

Device Description : DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Diamondback Peripheral - 10850000491202 Catalog Number : 7-10057-04

Device Description : DIAMONDBACK PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Diamondback Peripheral - 10850000491219 Catalog Number : 7-10057-05

Device Description : Diamondback Peripheral, Solid Crown, 1.25MM, 200CM shaft

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Diamondback Peripheral - 10850000491226 Catalog Number : 7-10057-06

Device Description : Diamondback Peripheral, Solid Crown, 1.50MM, 200CM shaft

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Diamondback Peripheral - 10850000491233 Catalog Number : 7-10057-07

Device Description : Diamondback Peripheral, Solid Crown, 1.75MM, 180CM shaft

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

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