Biosense Webster Inc

Address:31 Technology Drive, Suite 200,Irvine,CA,92618,US

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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, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING (DRF) (4) catheter, percutaneous, cardiac ablation, for treatment of atrial flutter (OAD) (4) Catheter, intracardiac mapping, high-density array (MTD) (3) Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation (OAE) (1) REPLACEMENT, OSSICULAR (STAPES) USING ABSORBABLE GELATIN MATERIAL (LBP) (1)

Premarket Exempt

Clear

nGEN Generator - 10846835018080 Catalog Number : D138402

Device Description : Generator

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : OAE, DRF, OAD, LBP

Prescription Use : Yes

Device Count : 1

VISITAG SURPOINT EPU - 10846835018554 Catalog Number : M660202SP

Device Description : EXT PROCESSING UNIT ACCESSORIE

Device Class : 3

Duns Number: 020163218

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

VISITAG SURPOINT EPU SPARE - 10846835018578 Catalog Number : M660201SP

Device Description : EXT PROCESSING UNIT ACCESSORIE

Device Class : 3

Duns Number: 020163218

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

VISITAG EXT PROCESSING UNIT ACCESS - 10846835018585 Catalog Number : M665701SP

Device Description : DOCK, VISITAG SURPOINT EPU SP

Device Class : 3

Duns Number: 020163218

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Lassostar NAV - 10846835020335 Catalog Number : D140401

Device Description : Circular Mapping Catheter

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

Lassostar NAV - 10846835020342 Catalog Number : D140402

Device Description : Circular Mapping Catheter

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

Lassostar NAV - 10846835020359 Catalog Number : D140403

Device Description : Circular Mapping Catheter

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

OCTARAY Mapping Catheter - 10846835021110 Catalog Number : D160902

Device Description : OCTA,GALAXY,2-5-2-5-2,D-CURVE

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

OCTARAY Mapping Catheter - 10846835021127 Catalog Number : D160903

Device Description : OCTA,GALAXY,3-3-3-3-3,D-CURVE

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

OCTARAY Mapping Catheter - 10846835021134 Catalog Number : D160906

Device Description : OCTA,GALAXY,3-3-3-3-3,F-CURVE

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

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