PENUMBRA, INC.

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, PERCUTANEOUS (DQY) (6) APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED (JCX) (3) Catheter, Thrombus Retriever (NRY) (1)

Premarket Exempt

No Yes

Clear

Penumbra System - 00814548010007 Catalog Number :

Device Description : PS ENGINE Canister Assembly

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : NRY

Prescription Use : No

Device Count : 1

Penumbra System - 00814548010014 Catalog Number :

Device Description : Aspiration Pump, 110V

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : JCX

Prescription Use : No

Device Count : 1

Penumbra System - 00814548010021 Catalog Number :

Device Description : Aspiration Pump 220V/230

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : JCX

Prescription Use : No

Device Count : 1

Penumbra System - 00814548010038 Catalog Number :

Device Description : Pump MAX Supplies

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : JCX

Prescription Use : No

Device Count : 1

Neuron - 00814548010045 Catalog Number :

Device Description : Neur070 DC STR, 105x8

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : DQY

Prescription Use : No

Device Count : 1

Neuron - 00814548010052 Catalog Number :

Device Description : Neur070 DC SHP, 105x8

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : DQY

Prescription Use : No

Device Count : 1

Neuron - 00814548010069 Catalog Number :

Device Description : Neur070 DC STR, 95x6

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : DQY

Prescription Use : No

Device Count : 1

Neuron - 00814548010076 Catalog Number :

Device Description : Neur070 DC SHP, 95x6

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : DQY

Prescription Use : No

Device Count : 1

Neuron - 00814548010083 Catalog Number :

Device Description : Neur6F DC STR, 105x12

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : DQY

Prescription Use : No

Device Count : 1

Neuron - 00814548010090 Catalog Number :

Device Description : Neur6F DC MP, 105x12

Device Class : 2

Duns Number: 191077671

Premarket Exempt : No

Product Code : DQY

Prescription Use : No

Device Count : 1

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