Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister— 510(k) K223176
Substantially EquivalentArgon Medical Devices, Inc.
FDA 510(k) clearance K223176 for Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister, Substantially Equivalent on 2023-04-10. Applicant: Argon Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Argon Medical Devices, Inc.
- Product code
- Code KRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Athens, TX, US
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Adverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
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.