MANIFOLD, DISPOSABLE 3 VALVE— 510(k) K790010
Substantially EquivalentCordis Corp.
FDA 510(k) clearance K790010 for MANIFOLD, DISPOSABLE 3 VALVE, Substantially Equivalent on 1979-02-01. Applicant: Cordis Corp.. Device class: 2.
Clearance details
- Applicant
- Cordis Corp.
- Product code
- Code FMG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code FMG
product code FMG- Death
- 14
- Malfunction
- 3,433
- Other
- 1
- Total
- 3,448
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.