ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

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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) (10)

Premarket Exempt

No Yes

Clear

HydroSteer™ - 05414734055093 Catalog Number : 405071

Device Description : Guidewires

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

HydroSteer™ - 05414734055109 Catalog Number : 405072

Device Description : Guidewires

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

HydroSteer™ - 05414734055116 Catalog Number : 405073

Device Description : Guidewires

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

HydroSteer™ - 05414734055123 Catalog Number : 405074

Device Description : Guidewires

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

HydroSteer™ - 05414734055130 Catalog Number : 405075

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

HydroSteer™ - 05414734055147 Catalog Number : 405076

Device Description : Guidewires

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

HydroSteer™ - 05414734055154 Catalog Number : 405077

Device Description : Guidewires

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

HydroSteer™ - 05414734055161 Catalog Number : 405078

Device Description : Guidewires

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

HydroSteer™ - 05414734055178 Catalog Number : 405079

Device Description : Guidewires

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

HydroSteer™ - 05414734055185 Catalog Number : 405080

Device Description : Guidewires

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

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