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

Cardiac ablation percutaneous catheter (LPB) (9) WIRE, GUIDE, CATHETER (DQX) (1)

Premarket Exempt

No Yes

Clear

HydroSteer™ - 05414734055192 Catalog Number : 405081

Device Description : Guidewires

Device Class : 2

Duns Number: 040960379

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Livewire™ - 05414734200226 Catalog Number : 402149

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 040960379

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Livewire™ - 05414734200233 Catalog Number : 402150

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 040960379

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Livewire™ - 05414734200240 Catalog Number : 402151

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 040960379

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Livewire™ - 05414734200257 Catalog Number : 402152

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 040960379

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Livewire™ - 05414734200271 Catalog Number : 402206

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 040960379

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Livewire™ - 05414734200288 Catalog Number : 402207

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 040960379

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Livewire™ - 05414734200295 Catalog Number : 402208

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 040960379

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Livewire™ - 05414734200301 Catalog Number : 402271

Device Description : Bi-Directional Ablation Catheter

Device Class : 3

Duns Number: 040960379

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Livewire™ - 05414734200318 Catalog Number : 402273

Device Description : Bi-Directional Ablation Catheter

Device Class : 3

Duns Number: 040960379

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

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