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™ - 00811806010212 Catalog Number : 9-ASD-028

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806010229 Catalog Number : 9-ASD-030

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806010236 Catalog Number : 9-ASD-032

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806010243 Catalog Number : 9-ASD-034

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806010250 Catalog Number : 9-ASD-036

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806010267 Catalog Number : 9-ASD-038

Device Description : Septal Occluder

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806010281 Catalog Number : 9-ASD-MF-018

Device Description : MF Septal Occluder Cribriform

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806010298 Catalog Number : 9-ASD-MF-025

Device Description : MF Septal Occluder Cribriform

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806010304 Catalog Number : 9-ASD-MF-030

Device Description : MF Septal Occluder Cribriform

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806010311 Catalog Number : 9-ASD-MF-035

Device Description : MF Septal Occluder Cribriform

Device Class : 3

Duns Number: 966215829

Premarket Exempt : No

Product Code : MLV

Prescription Use : Yes

Device Count : 1

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