DUAL LUMEN CATHETER— 510(k) K043581

Substantially Equivalent

Acmi Corporation

FDA 510(k) clearance K043581 for DUAL LUMEN CATHETER, Substantially Equivalent on 2005-03-03. Applicant: Acmi Corporation. Device class: 2.

Clearance details

Applicant: Acmi Corporation
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2004-12-28
Decision date: 2005-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.