Cleared Traditional

K830084 - ANGIOSCOPE

K830084 is an FDA 510(k) clearance for ANGIOSCOPE, manufactured by Trimedyne, Inc.. The device is a Class 2 Cardiovascular device with product code LYK cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K830084 · Trimedyne, Inc. · Cardiovascular device
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Jun 1983
Decision
142d
Days
Class 2
Risk

K830084 is an FDA 510(k) clearance for the ANGIOSCOPE. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Trimedyne, Inc. (Walker, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 142 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 Trimedyne, Inc. devices

FDA 510(k) Submission Details - K830084

510(k) Number K830084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date June 02, 1983
Days to Decision 142 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 125d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYK Device Classification - Class 2, Special Controls

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.