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

Cardiac ablation percutaneous catheter (LPB) (4) CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING (DRF) (3) catheter, percutaneous, cardiac ablation, for treatment of atrial flutter (OAD) (3)

Premarket Exempt

Clear

Celsius - 10846835000382 Catalog Number : D7TCDL252RT

Device Class : 3

Duns Number: 020163218

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Celsius DS - 10846835000399 Catalog Number : D7TCF8L162RT

Device Class : 3

Duns Number: 020163218

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Celsius - 10846835000405 Catalog Number : D7TCFL252RT

Device Class : 3

Duns Number: 020163218

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Celsius - 10846835000412 Catalog Number : D7TDL252RT

Device Class : 3

Duns Number: 020163218

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Celsius - 10846835000429 Catalog Number : D7TFL252RT

Device Class : 3

Duns Number: 020163218

Premarket Exempt : No

Product Code : LPB

Prescription Use : Yes

Device Count : 1

Celsius - 10846835000436 Catalog Number : D8BTCDL252RT

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

Celsius ThermoCool - 10846835000443 Catalog Number : DI7TCDLRT

Device Class : 3

Duns Number: 020163218

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Celsius ThermoCool - 10846835000450 Catalog Number : DI7TCFLRT

Device Class : 3

Duns Number: 020163218

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

WEBSTER - 10846835000467 Catalog Number : F5ADP282RT

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

WEBSTER - 10846835000474 Catalog Number : F5QF005RT

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

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