URE SIL EMBOLECTOMY/THROMBECTOMY CATH— 510(k) K812640
Substantially EquivalentUresil Corp.
FDA 510(k) clearance K812640 for URE SIL EMBOLECTOMY/THROMBECTOMY CATH, Substantially Equivalent on 1981-10-02. Applicant: Uresil Corp.. Device class: 2.
Clearance details
- Applicant
- Uresil Corp.
- Product code
- Code DXE
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code DXE
product code DXE- Death
- 27
- Injury
- 258
- Malfunction
- 2,266
- Total
- 2,551
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.