Cleaner Plus Thrombectomy System

Peripheral Mechanical Thrombectomy With Aspiration

Argon Medical Devices, Inc.

The following data is part of a premarket notification filed by Argon Medical Devices, Inc. with the FDA for Cleaner Plus Thrombectomy System.

Pre-market Notification Details

• Device ID: K211798
• 510k Number: K211798
• Device Name: Cleaner Plus Thrombectomy System
• Classification: Peripheral Mechanical Thrombectomy With Aspiration
• Applicant: Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751
• Contact: Ana Jimenez-hughes
• Correspondent: Ana Jimenez-hughes; Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751
• Product Code: QEW
• CFR Regulation Number: 870.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-06-10
• Decision Date: 2022-02-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00886333225781	K211798	000
00886333225774	K211798	000
00886333225767	K211798	000
00886333225750	K211798	000