STANICOR, OMNI-STAN,MOD 333B,334A GAMMA— 510(k) K792348

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K792348 for STANICOR, OMNI-STAN,MOD 333B,334A GAMMA, Substantially Equivalent on 1979-12-05. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code DTX
Advisory panel: Cardiovascular
Date received: 1979-11-19
Decision date: 1979-12-05
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, 2020-01-01 through 2026-04-23. 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.