Cleared Traditional

K904787 - CRI STEERABLE CATHETER CONTROL SYSTEM
(FDA 510(k) Clearance)

K904787 · Catheter Research C/O Burditt, Bowles & Radzius · Cardiovascular

Dec 1990

Decision

55d

Days

Class 2

Risk

K904787 is an FDA 510(k) clearance for the CRI STEERABLE CATHETER CONTROL SYSTEM, a System, Catheter Control, Steerable (Class II — Special Controls, product code DXX), submitted by Catheter Research C/O Burditt, Bowles & Radzius (Indianapolis, US). The FDA issued a Cleared decision on December 17, 1990, 55 days after receiving the submission on October 23, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number	K904787 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 1990
Decision Date	December 17, 1990
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—