Cleared Traditional

K964393 - CHASE RETROGRADE CARDIOPLEGIA CANNULA

K964393 is an FDA 510(k) clearance for CHASE RETROGRADE CARDIOPLEGIA CANNULA, manufactured by Chase Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K964393 · Chase Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
170d
Days
Class 2
Risk

K964393 is an FDA 510(k) clearance for the CHASE RETROGRADE CARDIOPLEGIA 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 April 23, 1997 after a review of 170 days - an extended review cycle.

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

FDA 510(k) Submission Details - K964393

510(k) Number K964393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1996
Decision Date April 23, 1997
Days to Decision 170 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 125d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

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 335
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K964393.
CHASE LEFT VENT SAFETY VALVE
K964391 · Chase Medical, Inc. · May 1997
CHASE AORTIC PERFUSION CANNULA
K970914 · Chase Medical, Inc. · May 1997
CHASE CORONARY OSTIAL PERFUSION CANNULA
K971041 · Chase Medical, Inc. · May 1997
CHASE AORTIC ARCH CANNULA
K964193 · Chase Medical, Inc. · Apr 1997
CHASE CURVED LEFT HEART VENT CATHETER
K964194 · Chase Medical, Inc. · Apr 1997
CHASE MULTIPLE PERFUSION SET
K964200 · Chase Medical, Inc. · Apr 1997