AGA MEDICAL CORPORATION

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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

Transcatheter septal occluder (MLV) (8) CATHETER, PERCUTANEOUS (DQY) (2)

Premarket Exempt

No Yes

Clear

AMPLATZER™ - 00811806011592 Catalog Number : 9-TVLP5F90/080

Device Description : Delivery System

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011783 Catalog Number : 9-VSD-MUSC-004

Device Description : VSD Muscular Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011790 Catalog Number : 9-VSD-MUSC-006

Device Description : VSD Muscular Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011806 Catalog Number : 9-VSD-MUSC-008

Device Description : VSD Muscular Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011813 Catalog Number : 9-VSD-MUSC-010

Device Description : VSD Muscular Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011820 Catalog Number : 9-VSD-MUSC-012

Device Description : VSD Muscular Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011837 Catalog Number : 9-VSD-MUSC-014

Device Description : VSD Muscular Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011844 Catalog Number : 9-VSD-MUSC-016

Device Description : VSD Muscular Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011851 Catalog Number : 9-VSD-MUSC-018

Device Description : VSD Muscular Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806012087 Catalog Number : 9-TV45X45-09F-100

Device Description : Delivery Sheath

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

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