Cleared Traditional

CRI CYNOSAR CATHETER (K924227) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K924227 is an FDA 510(k) clearance for the CRI CYNOSAR CATHETER. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Catheter Research C/O Burditt, Bowles & Radzius (Indianapolis, US). The FDA issued a Cleared decision on June 29, 1993 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Catheter Research C/O Burditt, Bowles & Radzius devices

Submission Details

510(k) Number K924227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 125d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.