ELECATH VENTRICULAR PACING THERMAL DILUTION CATH— 510(k) K844022

Name: FDA 510(k) clearance K844022
Creator: U.S. Food and Drug Administration
Published: 1984-11-20

Substantially Equivalent

Electro-Catheter Corp.

FDA 510(k) clearance K844022 for ELECATH VENTRICULAR PACING THERMAL DILUTION CATH, Substantially Equivalent on 1984-11-20. Applicant: Electro-Catheter Corp.. Device class: 2.

Clearance details

Applicant: Electro-Catheter Corp.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1984-10-15
Decision date: 1984-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rahway, NJ, US

Download summary PDF View on FDA.gov ↗

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