STANICOR, OMNI-STAN,MOD 333B,334A GAMMA— 510(k) K792348
Substantially EquivalentCordis Corp.
FDA 510(k) clearance K792348 for STANICOR, OMNI-STAN,MOD 333B,334A GAMMA, Substantially Equivalent on 1979-12-05. Applicant: Cordis Corp.. Device class: 2.
Clearance details
- Applicant
- Cordis Corp.
- Product code
- Code DTX
- Device class
- Class 2
- Regulation
- 21 CFR 870.4300
- 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 DTX
product code DTX- Death
- 3
- Malfunction
- 497
- Total
- 500
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.