ELECATH HEPARIN COATED THERMAL DILUTION— 510(k) K832787

Name: FDA 510(k) clearance K832787
Creator: U.S. Food and Drug Administration
Published: 1983-10-04

Substantially Equivalent

Electro-Catheter Corp.

FDA 510(k) clearance K832787 for ELECATH HEPARIN COATED THERMAL DILUTION, Substantially Equivalent on 1983-10-04. Applicant: Electro-Catheter Corp.. Device class: 1.

Clearance details

Applicant: Electro-Catheter Corp.
Product code: Code KYG
Device class: Class 1
Regulation: 21 CFR 886.4360
Advisory panel: Ophthalmic
Date received: 1983-08-16
Decision date: 1983-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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