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.
Clearance details
- Applicant
- Argon Medical Devices, Inc.
- Product code
- 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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- 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.