Cleared Traditional

CORDIS CONTRAST INJECTION LINES (K864141) - FDA 510(k) Clearance

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

K864141 · Cordis Corp. · Cardiovascular device
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Nov 1986
Decision
12d
Days
Class 2
Risk

K864141 is an FDA 510(k) clearance for the CORDIS CONTRAST INJECTION LINES. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on November 3, 1986 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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

Submission Details

510(k) Number K864141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1986
Decision Date November 03, 1986
Days to Decision 12 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
113d faster than avg
Panel avg: 125d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 173
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K864141.
SLIP-COAT(TM) CATHETERS
K882796 · Cook, Inc. · Jul 1988
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438 · C.R. Bard, Inc. · Nov 1987
DOUBLE LUMEN CATHETER
K872248 · Cordis Corp. · Aug 1987
TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER
K863137 · Terumo Medical Corp. · Oct 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673 · Medtronic Vascular · Sep 1986
SCHNEIDER-SHILEY FLUSHING CATHETER
K862466 · Shiley, Inc. · Aug 1986