SHAPE MEMORY MEDICAL INC

Address:807 Aldo Ave, Suite 109,Santa Clara,CA,95054,US

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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) (10)

Premarket Exempt

Clear

IMPEDE Embolization Plug - 00810041650009 Catalog Number : IMP-05

Device Description : IMPEDE Embolization Plug, 5mm

Device Class : 2

Duns Number: 025984823

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

IMPEDE Embolization Plug - 00810041650016 Catalog Number : IMP-07

Device Description : IMPEDE Embolization Plug, 7mm

Device Class : 2

Duns Number: 025984823

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

IMPEDE Embolization Plug - 00810041650023 Catalog Number : IMP-10

Device Description : IMPEDE Embolization Plug, 10mm

Device Class : 2

Duns Number: 025984823

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

IMPEDE-FX Embolization Plug - 00810041650030 Catalog Number : IMP-FX-06

Device Description : IMPEDE-FX Embolization Plug, 6mm

Device Class : 2

Duns Number: 025984823

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

IMPEDE-FX Embolization Plug - 00810041650047 Catalog Number : IMP-FX-08

Device Description : IMPEDE-FX Embolization Plug, 8mm

Device Class : 2

Duns Number: 025984823

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

IMPEDE-FX Embolization Plug - 00810041650054 Catalog Number : IMP-FX-12

Device Description : IMPEDE-FX Embolization Plug, 12mm

Device Class : 2

Duns Number: 025984823

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

IMPEDE Embolization Plug - B054IMP051 Catalog Number : IMP-05

Device Description : IMPEDE Embolization Plug 5mm

Device Class : 2

Duns Number: 025984823

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

IMPEDE Embolization Plug - B054IMP071 Catalog Number : IMP-07

Device Description : IMPEDE Embolization Plug 7mm

Device Class : 2

Duns Number: 025984823

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

IMPEDE Embolization Plug - B054IMP101 Catalog Number : IMP-10

Device Description : IMPEDE Embolization Plug 10mm

Device Class : 2

Duns Number: 025984823

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

IMPEDE-FX Embolization Plug - B054IMPFX061 Catalog Number : IMP-FX-06

Device Description : IMPEDE-FX Embolization Plug 6mm

Device Class : 2

Duns Number: 025984823

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

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