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

OCCLUDER, PATENT DUCTUS, ARTERIOSUS (MAE) (6) CATHETER, PERCUTANEOUS (DQY) (4)

Premarket Exempt

No Yes

Clear

AMPLATZER™ - 00811806010854 Catalog Number : 9-ITV09F180/80

Device Description : Delivery System

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010861 Catalog Number : 9-ITV09F45/80

Device Description : Delivery System

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010878 Catalog Number : 9-ITV10F45/80

Device Description : Delivery System

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010885 Catalog Number : 9-ITV12F45/80

Device Description : Delivery System

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011103 Catalog Number : 9-PDA-003

Device Description : Duct Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MAE

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011110 Catalog Number : 9-PDA-004

Device Description : Duct Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MAE

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011127 Catalog Number : 9-PDA-005

Device Description : Duct Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MAE

Prescription Use : Yes

Device Count : 1

Amplatzer - 00811806011134 Catalog Number : 9-PDA-006

Device Description : Duct Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MAE

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011141 Catalog Number : 9-PDA-007

Device Description : Duct Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MAE

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806011172 Catalog Number : 9-PDA2-03-04

Device Description : Duct Occluder II

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MAE

Prescription Use : Yes

Device Count : 1

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