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Cleaner Plus

FDA UDI

Class II (US FDA UDI)

by Argon Medical Devices, Inc.

Identity

Trade Name
Cleaner Plus FDA UDI
Generic Name
Thrombectomy rotational catheter FDA UDI
Device Name
Cleaner Plus®, Thrombectomy System, 18F OD x 115cm FDA UDI
Model / Reference
70071518 FDA UDI
Description
Cleaner Plus®, Thrombectomy System, 18F OD x 115cm FDA UDI

Identifiers

Catalog Number
70071518 FDA UDI
Primary DI / UDI-DI
00886333226801 FDA UDI
510(k) Number
K233909 FDA UDI
FDA Product Code
QEW FDA UDI
KRA FDA UDI
GMDN Term
Thrombectomy rotational catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5150 FDA UDI
870.1210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Thrombectomy suction catheterThrombectomy rotational catheter

Cleaner Plus by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thrombectomy rotational catheter.

Cleared under the same submission

K233909 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Argon Medical Devices, Inc.

Sources (1)

  • FDA UDI 72ec9d19-62d3-465f-b1c2-216c8804339b 38 fields · synced Jun 9, 2026