Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister— 510(k) K233909
Substantially EquivalentArgon Medical Devices, Inc.
FDA 510(k) clearance K233909 for Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister, Substantially Equivalent on 2024-03-28. 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.