Biosense Webster Inc

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

INTRODUCER, CATHETER (DYB) (5) CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING (DRF) (3) Catheter, ultrasound, intravascular (OBJ) (2)

Premarket Exempt

No

Clear

CoolFlow - 10846835000016 Catalog Number : CFT001

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

PREFACE - 10846835000023 Catalog Number : 301803A

Device Description : PREF.GUIDING SHEATH W/ANTR.CRV

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PREFACE - 10846835000030 Catalog Number : 301803MS

Device Description : PREF GUIDING SHEATH:MULTI-SHRT

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PREFACE - 10846835000047 Catalog Number : 301803M

Device Description : PREF.GUIDING SHEATH W/MULT.CRV

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PREFACE - 10846835000054 Catalog Number : 301803P

Device Description : PREF.GUIDING SHEATH W/POST.CRV

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PREFACE - 10846835000061 Catalog Number : 301805M

Device Description : PREF.GUIDING SHEATH W/ANTR.CRV

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

CoolFlow - 10846835000085 Catalog Number : CFP002

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

SOUNDSTAR - 10846835000139 Catalog Number : SNDSTR10

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : OBJ

Prescription Use : Yes

Device Count : 1

SOUNDSTAR - 10846835000153 Catalog Number : SNDSTR10G

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : OBJ

Prescription Use : Yes

Device Count : 1

WEBSTER - 10846835000177 Catalog Number : 1085122RT

Device Class : 2

Duns Number: 020163218

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

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