Neuron

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name: Neuron FDA UDI
Generic Name: Vascular microcatheter FDA UDI
Device Name: Neur070Select, 120BER FDA UDI
Model / Reference: PNS5F120BER-R FDA UDI
Description: Neur070Select, 120BER FDA UDI

Identifiers

Primary DI / UDI-DI: 00815948027923 FDA UDI
510(k) Number: K083125 FDA UDI
FDA Product Code: DQY FDA UDI
GMDN Term: Vascular microcatheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vascular microcatheter

Neuron by Penumbra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular microcatheter.

Knight Microcatheter — ZIEN Medical Technologies, LLC · Class II
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Renegade™ HI-FLO™ Kit — Boston Scientific · Class II
PROWLER — Medos International Sàrl · Class II
Merit Maestro® — Merit Medical Systems, Inc. · Class II
Direxion™ Fathom™-16 System — Boston Scientific · Class II
Direxion™ — Boston Scientific · Class II
SUPERCROSS — TELEFLEX INCORPORATED · Class II

Cleared under the same submission

K083125 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Penumbra, Inc.

Sources (1)

FDA UDI 5c9eaba5-e2eb-4e97-801a-3c6010b00e09 34 fields · synced May 30, 2026