CRI STEERABLE CATHETER CONTROL SYSTEM— 510(k) K904787

Name: FDA 510(k) clearance K904787
Creator: U.S. Food and Drug Administration
Published: 1990-12-17

Substantially Equivalent

Catheter Research C/O Burditt, Bowles & Radzius

FDA 510(k) clearance K904787 for CRI STEERABLE CATHETER CONTROL SYSTEM, Substantially Equivalent on 1990-12-17. 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: 1990-10-23
Decision date: 1990-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K914523 — CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL1992-01-10
K904785 — CRI CYNOSAR CATHETER1991-03-06
K900320 — CRI CYNOSAR CATHETER1990-09-14

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