Cleared Traditional

CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM (K970264) - FDA 510(k) Clearance

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

K970264 · Cordis Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
278d
Days
Class 2
Risk

K970264 is an FDA 510(k) clearance for the CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cordis Webster, Inc. (Baldwin Park, US). The FDA issued a Cleared decision on October 28, 1997 after a review of 278 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Webster, Inc. devices

Submission Details

510(k) Number K970264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1997
Decision Date October 28, 1997
Days to Decision 278 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 125d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 229
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K970264.
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K971608 · Cordis Corp. · Jul 1997
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K962746 · Cordis Corp. · Oct 1996
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