Cleared Traditional

K860858 - OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE

K860858 is an FDA 510(k) clearance for OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE, manufactured by Olympus Corp.. The device is a Class 2 Cardiovascular device with product code LYK cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K860858 · Olympus Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
258d
Days
Class 2
Risk

K860858 is an FDA 510(k) clearance for the OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on November 20, 1986 after a review of 258 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 Olympus Corp. devices

FDA 510(k) Submission Details - K860858

510(k) Number K860858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1986
Decision Date November 20, 1986
Days to Decision 258 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
133d slower than avg
Panel avg: 125d · This submission: 258d
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 K860858.
CVIS INSIGHT IMAGING CATHETER
K897153 · Cardiovascular Imaging Systems, Inc. · Mar 1990
ACS ANGIOSCOPE GUIDE WIRE
K883000 · Advanced Cardiovascular Systems, Inc. · Sep 1988
ACS CORONARY ANGIOSCOPIC CATHETER
K875108 · Advanced Cardiovascular Systems, Inc. · Sep 1988
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE
K842481 · American Edwards Laboratories · Oct 1984
ANGIOSCOPY CATHETER
K834547 · American Edwards Laboratories · Jun 1984
ANGIOSCOPY CATHETER
K832698 · American Edwards Laboratories · Nov 1983