Cleared Traditional

CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 (K050808) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050808 · Cardio-Optics, Inc. · Cardiovascular device
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Jul 2005
Decision
120d
Days
Class 2
Risk

K050808 is an FDA 510(k) clearance for the CORONARY SINUS ACCESS KIT, MODEL KCS8F-01. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Cardio-Optics, Inc. (Boulder, US). The FDA issued a Cleared decision on July 28, 2005 after a review of 120 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 Cardio-Optics, Inc. devices

Submission Details

510(k) Number K050808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2005
Decision Date July 28, 2005
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
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 40
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K050808.
Vena MicroAngioscope™ System
K253842 · Vena Medical Holdings Corp · Jan 2026
Vena MicroAngioscope™ System
K251767 · Vena Medical Holdings Corp · Oct 2025
KSEA FIBERSCOPE
K011793 · KARL STORZ Endoscopy-America, Inc. · Apr 2002
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · Smith & Nephew, Inc. · Nov 2001
KSEA VASCULAR FIBERSCOPES
K001408 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
K931464 · Baxter Healthcare Corp · Oct 1993