PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)— 510(k) K946279

Substantially Equivalent

Cobe Renal Care, Inc.

FDA 510(k) clearance K946279 for PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM), Substantially Equivalent on 1997-02-10. Applicant: Cobe Renal Care, Inc..

Clearance details

Applicant: Cobe Renal Care, Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 1994-12-27
Decision date: 1997-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.