ABBOTT VASCULAR

Address:26531 YNEZ RD.,Temecula,CA,92591,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, STEERABLE (DRA) (1) Mitral valve repair devices (NKM) (1)

Premarket Exempt

Clear

MITRACLIP - 08717648195914 Catalog Number : CDS0201

Device Description : CLIP DELIVERY SYSTEM, MITRACLIP US

Device Class : 3

Duns Number: 849716605

Premarket Exempt : No

Product Code : NKM

Prescription Use : Yes

Device Count : 1

MITRACLIP - 08717648195921 Catalog Number : SGC0101

Device Description : STEERABLE GUIDE CATHETER, MITRACLIP US

Device Class : 2

Duns Number: 849716605

Premarket Exempt : No

Product Code : DRA

Prescription Use : Yes

Device Count : 1

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