CHEMO-PORT— 510(k) K913386

Unknown

Hdc Corp.

FDA 510(k) clearance K913386 for CHEMO-PORT, Unknown on 1992-01-10. Applicant: Hdc Corp..

Clearance details

Applicant: Hdc Corp.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1991-07-29
Decision date: 1992-01-10
Decision: Unknown
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.