Cleared Traditional

CRI CYNOSAR CATHETER

K924227 · Catheter Research C/O Burditt, Bowles & Radzius · Cardiovascular
Jun 1993
Decision
312d
Days
Class 2
Risk

About This 510(k) Submission

K924227 is an FDA 510(k) clearance for the CRI CYNOSAR CATHETER, a Catheter, Steerable (Class II — Special Controls, product code DRA), submitted by Catheter Research C/O Burditt, Bowles & Radzius (Indianapolis, US). The FDA issued a Cleared decision on June 29, 1993, 312 days after receiving the submission on August 21, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K924227 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1992
Decision Date June 29, 1993
Days to Decision 312 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DRA — Catheter, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1280

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