Cleared Traditional

K890206 - E-Z-FLOW ANGIOGRAPHY CATHETERS (FDA 510(k) Clearance)

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

K890206 · E-Z-Em, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
122d
Days
Class 2
Risk

K890206 is an FDA 510(k) clearance for the E-Z-FLOW ANGIOGRAPHY CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Marlboro, US). The FDA issued a Cleared decision on May 19, 1989 after a review of 122 days - within the typical 510(k) review window.

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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K890206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1989
Decision Date May 19, 1989
Days to Decision 122 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 498
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K890206.
Arterial Pressure Monitoring Set/Tray
K254278 · Spectrum Vascular · Mar 2026
DualView Catheter
K250751 · Terumo Corporation · Jul 2025
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
K242966 · Gentuity, LLC · Jan 2025
pNOVUS 21 Microcatheter
K242420 · Phenox, Ltd. · Nov 2024
Impress Angiographic Catheter
K233268 · Merit Medical Systems, Inc. · May 2024
Zoom 6F Insert Catheters
K233975 · Imperative Care, Inc. · Apr 2024