Cleaner Plus Thrombectomy System— 510(k) K211798
Substantially EquivalentArgon Medical Devices, Inc.
FDA 510(k) clearance K211798 for Cleaner Plus Thrombectomy System, Substantially Equivalent on 2022-02-24. Applicant: Argon Medical Devices, Inc.. Device class: 2.
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
- Traditional
- Location
- Athens, TX, US
Recent devices under product code QEW
view allMore clearances from Argon Medical Devices, Inc.
view all- K252795 — ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit) +3 more
- K260028 — CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
- K251318 — VariFuse Adjustable Infusion Catheter
- K253741 — VStick Vascular Access Set
- K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)
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.