pNOVUS 21 Microcatheter (150cm)

FDA UDI

Class II (US FDA UDI)

by Phenox Limited

Identity

Trade Name: pNOVUS 21 Microcatheter (150cm) FDA UDI
Generic Name: Vascular microcatheter FDA UDI
Device Name: The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. FDA UDI
Model / Reference: PNOV-21-150 FDA UDI
Description: The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. FDA UDI

Identifiers

Primary DI / UDI-DI: 05391530910378 FDA UDI
510(k) Number: K242420 FDA UDI
FDA Product Code: DQO FDA UDI
QJP FDA UDI
GMDN Term: Vascular microcatheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 FDA UDI
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

Yes

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

Dimensions & Sizes

Size: Catheter Length — 150 Centimeter FDA UDI

Category: Vascular microcatheter

pNOVUS 21 Microcatheter (150cm) by Phenox Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vascular microcatheter.

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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
Lantern Delivery Catheter — PENUMBRA, INC. · Class II
Direxion™ Fathom™-16 System — Boston Scientific · Class II

Cleared under the same submission

K242420 also covers:

pNOVUS 21 Microcatheter (160cm) — PHENOX LIMITED

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: Phenox Limited

Sources (1)

FDA UDI 1b811a56-ecf2-40d9-839e-59fb40ab1589 35 fields · synced May 30, 2026