WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS— 510(k) K083712

Substantially Equivalent

Dipure, LLC

FDA 510(k) clearance K083712 for WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS, Substantially Equivalent on 2009-07-10. Applicant: Dipure, LLC.

Clearance details

Applicant: Dipure, LLC
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-15
Decision date: 2009-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

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.