Cleared Traditional

ULTRA-VU ANGIOSCOPE (K902329) - FDA 510(k) Clearance

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

K902329 · Angiolaz, Inc. · Cardiovascular device
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Aug 1990
Decision
90d
Days
Class 2
Risk

K902329 is an FDA 510(k) clearance for the ULTRA-VU ANGIOSCOPE. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Angiolaz, Inc. (Rockingham, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 876.1500 - 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 Angiolaz, Inc. devices

Submission Details

510(k) Number K902329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1990
Decision Date August 22, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LYK Angioscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - LYK Angioscope

All 40
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K902329.
Vena MicroAngioscope™ System
K253842 · Vena Medical Holdings Corp · Jan 2026
Vena MicroAngioscope™ System
K251767 · Vena Medical Holdings Corp · Oct 2025
KSEA FIBERSCOPE
K011793 · KARL STORZ Endoscopy-America, Inc. · Apr 2002
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · Smith & Nephew, Inc. · Nov 2001
KSEA VASCULAR FIBERSCOPES
K001408 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
K931464 · Baxter Healthcare Corp · Oct 1993