Cleared Traditional

CORDAY CORONARY SINUS INFUSION CATHETER (K865074) - FDA 510(k) Clearance

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

K865074 · Retroperfusion Systems, Inc. · Cardiovascular device
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May 1987
Decision
128d
Days
Class 2
Risk

K865074 is an FDA 510(k) clearance for the CORDAY CORONARY SINUS INFUSION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Retroperfusion Systems, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on May 6, 1987 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Retroperfusion Systems, Inc. devices

Submission Details

510(k) Number K865074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1986
Decision Date May 06, 1987
Days to Decision 128 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 317
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K865074.
USCI PROBING CATHETER
K890152 · C.R. Bard, Inc. · Aug 1989
USCI CORONARY INFUSION CATHETER
K891069 · C.R. Bard, Inc. · Aug 1989
MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE
K883174 · Baxter Healthcare Corp · Oct 1988
CENTRAL VENOUS CATHETER
K870075 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY
K870675 · Quinton, Inc. · Apr 1987
MODIFIED PTCA GUIDING CATHETERS
K862975 · Cordis Corp. · Sep 1986