ATRIUMS PDR THORACIC CATHETER— 510(k) K912645

Name: FDA 510(k) clearance K912645
Creator: U.S. Food and Drug Administration
Published: 1991-09-13

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K912645 for ATRIUMS PDR THORACIC CATHETER, Substantially Equivalent on 1991-09-13. Applicant: Atrium Medical Corp.. Device class: 1.

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code GBS
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1991-06-17
Decision date: 1991-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollis, NH, 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.