Cleared Traditional

K974774 - ENVY GUIDING CATHETER

K974774 is an FDA 510(k) clearance for ENVY GUIDING CATHETER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K974774 · Cook, Inc. · Cardiovascular device
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Oct 1998
Decision
298d
Days
Class 2
Risk

K974774 is an FDA 510(k) clearance for the ENVY GUIDING CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on October 16, 1998 after a review of 298 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 Cook, Inc. devices

FDA 510(k) Submission Details - K974774

510(k) Number K974774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1997
Decision Date October 16, 1998
Days to Decision 298 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
173d slower than avg
Panel avg: 125d · This submission: 298d
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 404
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K974774.
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SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
K982299 · Daig Corp. · Oct 1998
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
K981788 · Scimed Life Systems, Inc. · Aug 1998
SELECTOR DIAGNOSTIC CATHETER
K982077 · Boston Scientific Scimed, Inc. · Aug 1998
HEART CATH TRAY, STERILE, DISPOSABLE
K981441 · Trinity Laboratories, Inc. · Jul 1998