MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR— 510(k) K041179

Substantially Equivalent

Medegen Medical Manufacturing Services, Inc.

FDA 510(k) clearance K041179 for MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR, Substantially Equivalent on 2004-06-04. Applicant: Medegen Medical Manufacturing Services, Inc..

Clearance details

Applicant: Medegen Medical Manufacturing Services, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2004-05-06
Decision date: 2004-06-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Ontario, CA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.