Cleared Traditional

K970264 - CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM

K970264 is an FDA 510(k) clearance for CORDIS WEBSTER BRAIDED GUIDING SHEATH E..., manufactured by Cordis Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 278-day FDA review.

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

FDA 510(k) Submission Details - K970264

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
Combination Product No
PCCP Authorized No
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.

DYB Device Classification - Class 2, Special Controls

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 502
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K970264.
ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET
K970229 · Arrow Intl., Inc. · Feb 1998
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K974448 · Cordis Corp. · Feb 1998
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
K973007 · Datascope Corp. · Nov 1997
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM
K972684 · Innerdyne, Inc. · Oct 1997
HEARTPORT INTRODUCER SHEATH
K972570 · Heartport, Inc. · Oct 1997
PERCUTANEOUS VENOUS INTRODUCER 10264
K965167 · Medamicus, Inc. · Jul 1997