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 - 10850000491240 Catalog Number : 7-10057-08

Device Description : DIAMONDBACK PERIPHERAL, CLASSIC 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 - 10850000491257 Catalog Number : 7-10057-09

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

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Stealth - 10850000491264 Catalog Number : 7-10059-01

Device Description : STEALTH 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

Stealth - 10850000491271 Catalog Number : 7-10059-02

Device Description : STEALTH 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

Stealth - 10850000491288 Catalog Number : 7-10059-03

Device Description : STEALTH 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

Stealth - 10850000491295 Catalog Number : 7-10059-04

Device Description : STEALTH 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

Stealth - 10850000491301 Catalog Number : 7-10059-05

Device Description : STEALTH Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm shaft

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Stealth - 10850000491318 Catalog Number : 7-10059-06

Device Description : STEALTH Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm shaft

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Stealth - 10850000491325 Catalog Number : 7-10059-07

Device Description : STEALTH Peripheral, Radial Access OAD, 1.75mm, 30mm, 180cm shaft

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Stealth - 10850000491332 Catalog Number : 7-10059-08

Device Description : STEALTH PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT

Device Class : 2

Duns Number: 024954518

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

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