RIGHT ATRIAL CATHETER— 510(k) K822964

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K822964 for RIGHT ATRIAL CATHETER, Substantially Equivalent on 1982-11-30. Applicant: Quinton, Inc.. Device class: 2.

Clearance details

Applicant: Quinton, Inc.
Product code: Code LFJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1982-10-05
Decision date: 1982-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, 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.