Cleared Traditional

K953768 - CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER

K953768 is an FDA 510(k) clearance for CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTAB..., manufactured by Cordis Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K953768 · Cordis Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
100d
Days
Class 2
Risk

K953768 is an FDA 510(k) clearance for the CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Cordis Webster, Inc. (Baldwin Park, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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.

FDA 510(k) Submission Details - K953768

510(k) Number K953768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1995
Decision Date November 22, 1995
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 180
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K953768.
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
K953750 · Boston Scientific Corp · Mar 1996
CORDIS WESTER STAR CATHETER
K954390 · Cordis Webster, Inc. · Dec 1995
DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM
K953651 · Arrow Intl., Inc. · Nov 1995
ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS
K945229 · Arrow Intl., Inc. · Aug 1995
IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER
K946333 · Irvine Biomedical, Inc. · Jul 1995
HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER
K932388 · Heart Rhythm Technologies, Inc. · May 1995
K953768 · CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
Download PDF FDA Summary Cordis Webster, Inc.