PENUMBRA, INC.

Address:One Penumbra Place,Alameda,CA,94502,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

CATHETER, THROMBUS RETRIEVER (NRY) (7) CATHETER, PERCUTANEOUS (DQY) (3)

Premarket Exempt

No Yes

Clear

Neuron - 00814548010229 Catalog Number :

Device Description : Neur070Select, 130H1

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : DQY

Prescription Use : No

Device Count : 1

Neuron - 00814548010236 Catalog Number :

Device Description : Neur070Select, 130SIM

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : DQY

Prescription Use : No

Device Count : 1

Penumbra System - 00814548010304 Catalog Number :

Device Description : PS RP Catheter 026

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : NRY

Prescription Use : No

Device Count : 1

Penumbra System - 00814548010311 Catalog Number :

Device Description : PS RP Catheter 032

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : NRY

Prescription Use : No

Device Count : 1

Penumbra System - 00814548010328 Catalog Number :

Device Description : PS RP Catheter 041

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : NRY

Prescription Use : No

Device Count : 1

PX SLIM Delivery Microcatheter - 00814548010342 Catalog Number :

Device Description : PXSLIM 150Micro, 90Deg

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : DQY

Prescription Use : No

Device Count : 1

Penumbra System - 00814548010359 Catalog Number :

Device Description : PS Separator 026

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : NRY

Prescription Use : No

Device Count : 1

Penumbra System - 00814548010366 Catalog Number :

Device Description : PS Separator 032

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : NRY

Prescription Use : No

Device Count : 1

Penumbra System - 00814548010373 Catalog Number :

Device Description : PS Separator 041

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : NRY

Prescription Use : No

Device Count : 1

Penumbra System - 00814548010380 Catalog Number :

Device Description : PS Separator 054

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : NRY

Prescription Use : No

Device Count : 1

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