Cleared Traditional

ANGIOSCOPE

K934696 · Intramed Laboratories, Inc. · Cardiovascular
Jan 1994
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K934696 is an FDA 510(k) clearance for the ANGIOSCOPE, a Angioscope (Class II — Special Controls, product code LYK), submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on January 18, 1994, 110 days after receiving the submission on September 30, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K934696 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1993
Decision Date January 18, 1994
Days to Decision 110 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

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