Cleared Traditional

K801865 - CORDIS FLOW DIRECTED BALLOON CATHETER

K801865 is an FDA 510(k) clearance for CORDIS FLOW DIRECTED BALLOON CATHETER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K801865 · Cordis Corp. · Cardiovascular device
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Aug 1980
Decision
15d
Days
Class 2
Risk

K801865 is an FDA 510(k) clearance for the CORDIS FLOW DIRECTED BALLOON CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Cordis Corp. devices

FDA 510(k) Submission Details - K801865

510(k) Number K801865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1980
Decision Date August 20, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 57
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K801865.
SWAN-GANZ FLOW-DIRECTED THERMODILUTION
K810352 · American Edwards Laboratories · Mar 1981
SWAN-GANZ VIP THERMODILUTION CATHETER
K810124 · American Edwards Laboratories · Feb 1981
TORQUE CONTROL BALLOON CATHETER
K802338 · Cordis Corp. · Oct 1980
CATHETER, USCI GRUNTZIG/BALLOON
K782071 · C.R. Bard, Inc. · Dec 1978
CATHETER, PACING/MONITORING
K772059 · Electro-Catheter Corp. · Nov 1977
CATHETER, GRUNTZIG, BALLON
K770522 · Cook, Inc. · Mar 1977