PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH— 510(k) K862098

Substantially Equivalent

Hall/Mccollum Laboratories, Inc.

FDA 510(k) clearance K862098 for PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH, Substantially Equivalent on 1986-11-12. Applicant: Hall/Mccollum Laboratories, Inc..

Clearance details

Applicant: Hall/Mccollum Laboratories, Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1986-06-02
Decision date: 1986-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.