Cleared Traditional

ULTRA-VU ANGIOSCOPE

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

About This 510(k) Submission

K902329 is an FDA 510(k) clearance for the ULTRA-VU ANGIOSCOPE, a Angioscope (Class II — Special Controls, product code LYK), submitted by Angiolaz, Inc. (Rockingham, US). The FDA issued a Cleared decision on August 22, 1990, 90 days after receiving the submission on May 24, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K902329 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1990
Decision Date August 22, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code LYK — Angioscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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