Biosense Webster Inc

Address:15715 ARROW HWY.,IRWINDALE,CA,91706,US

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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, intracardiac mapping, high-density array (MTD) (4) CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING (DRF) (3)

Premarket Exempt

Clear

OCTARAY Mapping Catheter - 10846835021141 Catalog Number : D160901

Device Description : OCTA,PERSEID,2-2-2-2-2,D-CURVE

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

OCTARAY Mapping Catheter - 10846835021158 Catalog Number : D160905

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

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

OCTARAY Mapping Catheter - 10846835021233 Catalog Number : D160904

Device Description : OCTA,PERSEID,2-2-2-2-2,F-CURVE

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

CARTO 3 System eco Interface Cable - 10846835022056 Catalog Number : D134402

Device Description : Interface Cable

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

OPTRELL - 10846835023015 Catalog Number : D140901

Device Description : Mapping Catheter with TRUEref Technology

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

OPTRELL - 10846835023022 Catalog Number : D140902

Device Description : Mapping Catheter with TRUEref Technology

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

Reference Patch CARTO 3 - 20846835000129 Catalog Number : CREFP6

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

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