SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX— 510(k) K993698

Substantially Equivalent

Mogul Enterprises

FDA 510(k) clearance K993698 for SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX, Substantially Equivalent on 2000-08-16. Applicant: Mogul Enterprises.

Clearance details

Applicant: Mogul Enterprises
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1999-11-02
Decision date: 2000-08-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Jose, CA, US

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Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.