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

Wire, Guide, Catheter (DQX) (7) Catheter, Peripheral, Atherectomy (MCW) (3)

Premarket Exempt

No Yes

Clear

DIAMONDBACK - 10850026568445 Catalog Number : 7-10057-10

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

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

DIAMONDBACK - 10850026568469 Catalog Number : 7-10031-13

Device Description : DIAMONDBACK EXCHANGEABLE CARTRIDGE, 2.00 MAX CROWN, 145CM SHAFT

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

DIAMONDBACK - 10850026568476 Catalog Number : 7-10030-13

Device Description : DIAMONDBACK EXCHANGEABLE SYSTEM, 2.00 MAX CROWN, 145CM SHAFT

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Shepherd - 10850026568537 Catalog Number : 7-10096-01

Device Description : 0.014" Shepherd ES Guidewire - straight 195 cm - 4 gms

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Shepherd - 10850026568544 Catalog Number : 7-10096-02

Device Description : 0.014" Shepherd ES Guidewire - straight 300 cm - 4 gms

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Shepherd - 10850026568551 Catalog Number : 7-10096-03

Device Description : 0.018" Shepherd ES Guidewire - straight 195 cm - 4 gms

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Shepherd - 10850026568568 Catalog Number : 7-10096-04

Device Description : 0.018" Shepherd ES Guidewire - straight 300 cm - 4 gms

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Shepherd - 10850026568575 Catalog Number : 7-10096-05

Device Description : 0.014" Shepherd ES Guidewire - straight 195 cm - 6 gms

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Shepherd - 10850026568582 Catalog Number : 7-10096-06

Device Description : 0.014" Shepherd ES Guidewire - straight 300 cm - 6 gms

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Shepherd - 10850026568599 Catalog Number : 7-10096-07

Device Description : 0.018" Shepherd ES Guidewire - straight 195 cm - 6 gms

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

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