CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister— 510(k) K260028
Substantially EquivalentArgon Medical Devices, Inc.
FDA 510(k) clearance K260028 for CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister, Substantially Equivalent on 2026-02-05. Applicant: Argon Medical Devices, Inc.. Device class: 2.
Summary
Argon Medical Devices lists three CLEANER Vac items: the Thrombectomy System, the Aspiration Catheter with Handpiece, and the Aspiration Canister. They're filed under product code QEW, peripheral mechanical thrombectomy with aspiration, and the record doesn't describe them beyond those names.
Class II, 21 CFR 870.5150. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).
Argon Medical Devices filed from Athens, Texas. The decision came 31 calendar days after FDA received it (January 5 to February 5, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Argon Medical Devices, Inc.
- Product code
- Product code QEW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Athens, TX, US
Recent devices under product code QEW
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view all- K252795 — ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit) +3 more
- K251318 — VariFuse Adjustable Infusion Catheter
- K253741 — VStick Vascular Access Set
- K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)
- K241145 — TLAB® Transvenous Liver Biopsy System (TF-18C)
Adverse events under product code QEW
product code QEW- Death
- 126
- Injury
- 282
- Malfunction
- 820
- Total
- 1,228
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.