Cleared Traditional

K834547 - ANGIOSCOPY CATHETER

K834547 is the FDA 510(k) clearance for ANGIOSCOPY CATHETER by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code LYK) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K834547 · American Edwards Laboratories · Cardiovascular device
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Jun 1984
Decision
167d
Days
Class 2
Risk

K834547 is an FDA 510(k) clearance for the ANGIOSCOPY CATHETER. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by American Edwards Laboratories (Walker, US). The FDA issued a Cleared decision on June 11, 1984 after a review of 167 days - an extended review cycle.

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 American Edwards Laboratories devices

Submission Details

510(k) Number K834547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1983
Decision Date June 11, 1984
Days to Decision 167 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
42d slower than avg
Panel avg: 125d · This submission: 167d
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 19
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K834547.
ACS CORONARY ANGIOSCOPIC CATHETER
K875108 · Advanced Cardiovascular Systems, Inc. · Sep 1988
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
K860858 · Olympus Corp. · Nov 1986
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE
K842481 · American Edwards Laboratories · Oct 1984
ANGIOSCOPY CATHETER
K832698 · American Edwards Laboratories · Nov 1983
ANGIOSCOPE
K830084 · Trimedyne, Inc. · Jun 1983