Cleared Traditional

K883000 - ACS ANGIOSCOPE GUIDE WIRE

K883000 is the FDA 510(k) clearance for ACS ANGIOSCOPE GUIDE WIRE by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code LYK) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K883000 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Sep 1988
Decision
72d
Days
Class 2
Risk

K883000 is an FDA 510(k) clearance for the ACS ANGIOSCOPE GUIDE WIRE. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 28, 1988 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K883000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1988
Decision Date September 28, 1988
Days to Decision 72 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
53d faster than avg
Panel avg: 125d · This submission: 72d
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 K883000.
OLYMPUS AF ANGIOSCOPE SYSTEM
K911278 · Olympus Corp. · Jul 1991
4.5F IMAGECATH ANGIOSCOPE
K905083 · Baxter Healthcare Corp · Jun 1991
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
K895538 · Trimedyne, Inc. · Apr 1990
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