6F HYDROLYSER THROMBECTOMY CATHETER— 510(k) K990771
Substantially EquivalentCordis Corp.
FDA 510(k) clearance K990771 for 6F HYDROLYSER THROMBECTOMY CATHETER, Substantially Equivalent on 1999-06-25. Applicant: Cordis Corp.. Device class: 2.
Clearance details
- Applicant
- Cordis Corp.
- Product code
- Code QEZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami Lakes, FL, US
Recent devices under product code QEZ
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Adverse events under product code QEZ
product code QEZ- Death
- 24
- Total
- 24
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.