PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35— 510(k) K070643

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K070643 for PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35, Substantially Equivalent on 2007-11-02. Applicant: Gambro, Inc..

Clearance details

Applicant: Gambro, Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2007-03-08
Decision date: 2007-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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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.