Cleared Traditional

COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (K965214) - FDA 510(k) Clearance

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

K965214 · Coeur Laboratories, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
88d
Days
Class 2
Risk

K965214 is an FDA 510(k) clearance for the COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002). Classified as Gas Control Unit, Cardiopulmonary Bypass (product code DTX), Class II - Special Controls.

Submitted by Coeur Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coeur Laboratories, Inc. devices

Submission Details

510(k) Number K965214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1996
Decision Date March 28, 1997
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTX Gas Control Unit, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4300
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.