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Neuron Delivery Catheter (115cm/12cm)
EUDAMEDFDA UDIClass III (EU MDR)
Ref PND6F11512Model Delivery Catheter
Identity
- Trade Name
- Neuron Delivery Catheter (115cm/12cm) EUDAMEDNeuron FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Neuron Intracranial Access System EUDAMEDNeur6F DC STR, 115x12 FDA UDI
- Model / Reference
- Delivery Catheter EUDAMEDPND6F11512 EUDAMEDFDA UDI
- Description
- Neur6F DC STR, 115x12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-NeuronET EUDAMED00814548010120 FDA UDI
- Basic UDI-DI
- B-NeuronET EUDAMED
- 510(k) Number
- K082290 FDA UDI
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular guidewire introduction sleeve
Neuron Delivery Catheter (115cm/12cm) by Penumbra, Inc. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular guidewire introduction sleeve.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-NeuronET | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
- EUDAMED SRN
- US-MF-000008514
- Authorised Representative
- Penumbra Europe GmbH DE-AR-000004997
Sources (2)
- EUDAMED 8d36e598-105d-4b24-aaa4-d18168ef31d1 61 fields · synced Jun 19, 2026
- FDA UDI 4852b577-51a6-4f91-a8eb-c079d1fbd3e6 34 fields · synced May 30, 2026