Firefly Peritoneal Dialysis Connector Disinfection System— 510(k) K151620

Substantially Equivalent

Puracath Medical, Inc.

FDA 510(k) clearance K151620 for Firefly Peritoneal Dialysis Connector Disinfection System, Substantially Equivalent on 2016-01-20. Applicant: Puracath Medical, Inc..

Clearance details

Applicant: Puracath Medical, Inc.
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 2015-06-16
Decision date: 2016-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDJ

product code KDJ

Death: 298
Injury: 9,221
Malfunction: 8,438
Other: 1
Total: 17,958

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.