Cleared Traditional

K924227 - CRI CYNOSAR CATHETER

K924227 is an FDA 510(k) clearance for CRI CYNOSAR CATHETER, manufactured by Catheter Research C/O Burditt, Bowles & Radzius. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Traditional 510(k) pathway after a 312-day FDA review.

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

FDA 510(k) Submission Details - K924227

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.

DRA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DRA Catheter, Steerable

All 37
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K924227.
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · St Jude Medical · Jan 2006
LYSUS INFUSION SYSTEM
K050472 · Ekos Corp. · Mar 2005
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
K040165 · St Jude Medical · May 2004
RESPONSE(TM) STEERABLE CATHETER
K913940 · Daig Corp. · Jan 1993
ADULT VENT CATHETER
K834352 · Dlp, Inc. · Jan 1984