Cleared Traditional

CRI ELECTRONIC CONTROL SYSTEM

K924125 · Catheter Research C/O Burditt, Bowles & Radzius · Cardiovascular
May 1993
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K924125 is an FDA 510(k) clearance for the CRI ELECTRONIC 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 May 26, 1993, 282 days after receiving the submission on August 17, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K924125 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1992
Decision Date May 26, 1993
Days to Decision 282 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DXX — System, Catheter Control, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1290