Cleared Traditional

5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER (K970854) - FDA 510(k) Clearance

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

K970854 · Cordis Corp. · Cardiovascular device
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Sep 1997
Decision
204d
Days
Class 2
Risk

K970854 is an FDA 510(k) clearance for the 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on September 30, 1997 after a review of 204 days - an extended review 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: 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 Cordis Corp. devices

Submission Details

510(k) Number K970854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1997
Decision Date September 30, 1997
Days to Decision 204 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
79d slower than avg
Panel avg: 125d · This submission: 204d
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 K970854.
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K974559 · Scimed Life Systems, Inc. · Feb 1998
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
K973401 · Cordis Corp. · Nov 1997
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS
K965112 · Medline Industries, Inc. · Oct 1997
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
K970207 · Boston Scientific Corp · Jul 1997
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
K971607 · Boston Scientific Corp · Jul 1997
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER
K971646 · Cordis Corp. · Jul 1997