Cleared Traditional

K875108 - ACS CORONARY ANGIOSCOPIC CATHETER

K875108 is an FDA 510(k) clearance for ACS CORONARY ANGIOSCOPIC CATHETER, manufactured by Advanced Cardiovascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code LYK cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K875108 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Sep 1988
Decision
288d
Days
Class 2
Risk

K875108 is an FDA 510(k) clearance for the ACS CORONARY ANGIOSCOPIC CATHETER. 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 27, 1988 after a review of 288 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 Advanced Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K875108

510(k) Number K875108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1987
Decision Date September 27, 1988
Days to Decision 288 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
163d slower than avg
Panel avg: 125d · This submission: 288d
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.

Regulatory Peers - LYK Angioscope

All 23
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K875108.
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
K895538 · Trimedyne, Inc. · Apr 1990
CVIS INSIGHT IMAGING CATHETER
K897153 · Cardiovascular Imaging Systems, Inc. · Mar 1990
ACS ANGIOSCOPE GUIDE WIRE
K883000 · 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
K834547 · American Edwards Laboratories · Jun 1984