NEO-CARE DUAL LUMEN UMBILICAL CATHETER— 510(k) K963972

Substantially Equivalent

Klein-Baker Medical, Inc.

FDA 510(k) clearance K963972 for NEO-CARE DUAL LUMEN UMBILICAL CATHETER, Substantially Equivalent on 1996-12-24. Applicant: Klein-Baker Medical, Inc..

Clearance details

Applicant: Klein-Baker Medical, Inc.
Product code: Code FOS
Advisory panel: General Hospital
Date received: 1996-10-03
Decision date: 1996-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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Adverse events under product code FOS

product code FOS

Death: 12
Other: 1
Total: 13

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.