Edwards Lifesciences LLC

Address:ONE EDWARDS WAY,IRVINE,CA,92614,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, continuous flush (KRA) (8) CATHETER, FLOW DIRECTED (DYG) (5) CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (5) CATHETER, OXIMETER, FIBEROPTIC (DQE) (5) TRANSDUCER, PRESSURE, CATHETER TIP (DXO) (4) Transducer, Pressure, Catheter Tip (DXO) (1)

Premarket Exempt

No Yes

Clear

TruWave - 00690103011548 Catalog Number : PXCMK315

Device Description : PRESSURE MONITORING SET

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 00690103014747 Catalog Number : PXMK318

Device Description : PRESSURE MONITORING SET

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE, VAMP - 00690103016581 Catalog Number : PXVK282

Device Description : PRESSURE MONITORING KIT - STERILE

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO, KRA

Prescription Use : Yes

Device Count : 1

TRUWAVE, VAMP - 00690103016765 Catalog Number : PXVMP2X22

Device Description : PRESSURE MONITORING SET

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRA, DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE, VAMP - 00690103016802 Catalog Number : PXVMP3X32

Device Description : PRESSURE MONITORING SET

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRA, DXO

Prescription Use : Yes

Device Count : 1

SWAN-GANZ TRUE SIZE - 00690103017236 Catalog Number : S111F7

Device Description : SWAN-GANZ TRUE SIZE MONITORING "S" TIP CATHETER

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DYG, DQE, KRA, DQO

Prescription Use : Yes

Device Count : 1

SWAN-GANZ CONTROLCATH TRUE SIZE - 00690103017243 Catalog Number : S144F7

Device Description : SWAN-GANZ POLYMER BLEND TRUE SIZE S-TIP CONTROLCATH TD

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DQO, DYG, KRA, DQE

Prescription Use : Yes

Device Count : 1

SWAN-GANZ HI-SHORE TRUE SIZE - 00690103017823 Catalog Number : T111F7

Device Description : SWAN-GANZ TRUE SIZE HI-SHORE MONITORING "T" TIP CATHETER

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DYG, DQE, KRA, DQO

Prescription Use : Yes

Device Count : 1

SWAN-GANZ HI-SHORE TRUE SIZE - 00690103017830 Catalog Number : T123F6

Device Description : HI TORQUE SG FLOW DIRECTED MONIT CATH W/ BONDED BALLOON

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DQE, DYG, KRA, DQO

Prescription Use : Yes

Device Count : 1

SWAN-GANZ TRUE SIZE - 00690103018295 Catalog Number : TS105F5

Device Description : SWAN-GANZ TRUE SIZE THERMODULTION CATHETER, 5F

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DYG, DQE, KRA, DQO

Prescription Use : Yes

Device Count : 1

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