Red 43

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name: RED 43 FDA UDI
Generic Name: Thrombectomy suction catheter FDA UDI
Device Name: Reperfusion Catheter RED 43 Kit, 167cm, 110 Tubing, no CE FDA UDI
Model / Reference: RED43HFKIT167-A FDA UDI
Description: Reperfusion Catheter RED 43 Kit, 167cm, 110 Tubing, no CE FDA UDI

Identifiers

Primary DI / UDI-DI: 00815948025813 FDA UDI
510(k) Number: K222808 FDA UDI
FDA Product Code: NRY FDA UDI
GMDN Term: Thrombectomy suction catheter 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Thrombectomy suction catheter

Red 43 by Penumbra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Trevo — Stryker Corp.
Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
Solitaire™ — Micro Therapeutics, Inc. · Class II
Stroke Fast Pack — Stryker Corp.
SmartClaw™ — Boston Scientific · Class II

Cleared under the same submission

K222808 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 c39b1faf-0844-430a-9e00-763a2e5a6b24 34 fields · synced May 30, 2026