Cleared Traditional

K964198 - CAHSE AORTIC ROOT CANNULA

K964198 is the FDA 510(k) clearance for CAHSE AORTIC ROOT CANNULA by Chase Medical, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K964198 · Chase Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
149d
Days
Class 2
Risk

K964198 is an FDA 510(k) clearance for the CAHSE AORTIC ROOT CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Chase Medical, Inc. (Richardson, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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. Standard predicate reliance. 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 Chase Medical, Inc. devices

Submission Details

510(k) Number K964198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1996
Decision Date March 19, 1997
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 125d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 255
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K964198.
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
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CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
K972503 · Sorin Group Italia S.R.L. · Aug 1997
RMI HEMOCONCENTRACTOR TUBING SET
K961927 · Research Medical, Inc. · Aug 1996
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET
K953945 · Dlp, Inc. · Mar 1996
FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER
K955818 · Quest Medical, Inc. · Mar 1996