Cleared Traditional

K970854 - 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CAT...

K970854 is an FDA 510(k) clearance for 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CAT..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 204-day FDA review.

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

FDA 510(k) Submission Details - K970854

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.

DQO Device Classification - Class 2, Special Controls

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 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K970854.
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
K973401 · Cordis Corp. · Nov 1997
RETRIEVER II
K964210 · Target Therapeutics · Oct 1997
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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