DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)— 510(k) K010399

Substantially Equivalent

Diatek, Inc.

FDA 510(k) clearance K010399 for DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM), Substantially Equivalent on 2001-08-14. Applicant: Diatek, Inc..

Clearance details

Applicant: Diatek, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2001-02-09
Decision date: 2001-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

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Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

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.