IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS— 510(k) K946168

Substantially Equivalent

Ivac Corporation

FDA 510(k) clearance K946168 for IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS, Substantially Equivalent on 1996-03-21. Applicant: Ivac Corporation.

Clearance details

Applicant: Ivac Corporation
Product code: Code LZH
Advisory panel: General Hospital
Date received: 1994-12-19
Decision date: 1996-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code LZH

product code LZH

Death: 12
Malfunction: 4,186
Total: 4,198

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.