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

Device, Vascular, for Promoting Embolization (KRD) (9) TAPE, MEASURING, RULERS AND CALIPERS (FTY) (1)

Premarket Exempt

No Yes

Clear

Amplatzer™ - 00811806010335 Catalog Number : 9-ASD-SZP

Device Description : Sizing Plate

Device Class : 1

Duns Number: 966215829

Premarket Exempt : Yes

Product Code : FTY

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010342 Catalog Number : 9-AVP2-003

Device Description : Vascular Plug II

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010359 Catalog Number : 9-AVP2-004

Device Description : Vascular Plug II

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010366 Catalog Number : 9-AVP2-006

Device Description : Vascular Plug II

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010373 Catalog Number : 9-AVP2-008

Device Description : Vascular Plug II

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010380 Catalog Number : 9-AVP2-010

Device Description : Vascular Plug II

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010397 Catalog Number : 9-AVP2-012

Device Description : Vascular Plug II

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010403 Catalog Number : 9-AVP2-014

Device Description : Vascular Plug II

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010410 Catalog Number : 9-AVP2-016

Device Description : Vascular Plug II

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806010427 Catalog Number : 9-AVP2-018

Device Description : Vascular Plug II

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

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