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

RING, ANNULOPLASTY (KRH) (10)

Premarket Exempt

No Yes

Clear

CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL - 00690103020052 Catalog Number : 4400M26

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL - 00690103020069 Catalog Number : 4400M28

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL - 00690103020076 Catalog Number : 4400M30

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL - 00690103020083 Catalog Number : 4400M32

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL - 00690103020090 Catalog Number : 4400M34

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL - 00690103020106 Catalog Number : 4400M36

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL - 00690103020113 Catalog Number : 4400M38

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL - 00690103020120 Catalog Number : 4400M40

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL - 00690103020212 Catalog Number : 4450M24

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL - 00690103020229 Catalog Number : 4450M26

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRH

Prescription Use : No

Device Count : 1

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