CRI ELECTRONIC CONTROL SYSTEM— 510(k) K924125

Name: FDA 510(k) clearance K924125
Creator: U.S. Food and Drug Administration
Published: 1993-05-26

Substantially Equivalent

Catheter Research C/O Burditt, Bowles & Radzius

FDA 510(k) clearance K924125 for CRI ELECTRONIC CONTROL SYSTEM, Substantially Equivalent on 1993-05-26. Applicant: Catheter Research C/O Burditt, Bowles & Radzius. Device class: 2.

Clearance details

Applicant: Catheter Research C/O Burditt, Bowles & Radzius
Product code: Code DXX
Device class: Class 2
Regulation: 21 CFR 870.1290
Advisory panel: Cardiovascular
Date received: 1992-08-17
Decision date: 1993-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K904785 — CRI CYNOSAR CATHETER1991-03-06
K904787 — CRI STEERABLE CATHETER CONTROL SYSTEM1990-12-17
K900320 — CRI CYNOSAR CATHETER1990-09-14

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