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

CATHETER, PERCUTANEOUS (DQY) (5) Device, Vascular, for Promoting Embolization (KRD) (5)

Premarket Exempt

No Yes

Clear

AMPLATZER™ - 00811806012094 Catalog Number : 9-TV45X45-10F-100

Device Description : Delivery Sheath

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806012100 Catalog Number : 9-TV45X45-12F-100

Device Description : Delivery Sheath

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806012117 Catalog Number : 9-TV45X45-13F-100

Device Description : Delivery Sheath

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806012346 Catalog Number : 9-AVP038-004

Device Description : Vascular Plug 4

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806012353 Catalog Number : 9-AVP038-005

Device Description : Vascular Plug 4

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806012360 Catalog Number : 9-AVP038-006

Device Description : Vascular Plug 4

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806012377 Catalog Number : 9-AVP038-007

Device Description : Vascular Plug 4

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Amplatzer™ - 00811806012384 Catalog Number : 9-AVP038-008

Device Description : Vascular Plug 4

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806012476 Catalog Number : 9-TV2-05F120

Device Description : Delivery Sheath

Device Class : 2

Duns Number: 966215829

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

AMPLATZER™ - 00811806012513 Catalog Number : 9-TV2-06F120

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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