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) (10)

Premarket Exempt

No Yes

Clear

AMPLATZER™ - 05415067019196 Catalog Number : 9-ASD-011

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 05415067019202 Catalog Number : 9-ASD-012

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 05415067019219 Catalog Number : 9-ASD-013

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 05415067019226 Catalog Number : 9-ASD-014

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 05415067019233 Catalog Number : 9-ASD-015

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 05415067019240 Catalog Number : 9-ASD-016

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 05415067019257 Catalog Number : 9-ASD-017

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 05415067019264 Catalog Number : 9-ASD-018

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 05415067019271 Catalog Number : 9-ASD-019

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 05415067019288 Catalog Number : 9-ASD-020

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

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