Cleared Traditional

K926433 - 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45

K926433 is an FDA 510(k) clearance for 4.5F IMAGECATH CORONARY ANGIOSCOPE, manufactured by Baxter Edwards. The device is a Class 2 Cardiovascular device with product code LYK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K926433 · Baxter Edwards · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
90d
Days
Class 2
Risk

K926433 is an FDA 510(k) clearance for the 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Baxter Edwards (Irvine, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 90 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 Baxter Edwards devices

FDA 510(k) Submission Details - K926433

510(k) Number K926433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date March 23, 1993
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 22
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K926433.
APPLIED MEDICAL OPTICAL VALVULOTOME
K945591 · Applied Medical Resources · Feb 1995
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
K931464 · Baxter Healthcare Corp · Oct 1993
DIAGNOSTIC INTRAVASCULAR CATHETER
K930758 · Applied Medical Resources · Sep 1993
CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE
K924554 · Clarus Medical Systems, Inc. · Feb 1993
OLYMPUS AF ANGIOSCOPE SYSTEM
K911278 · Olympus Corp. · Jul 1991
4.5F IMAGECATH ANGIOSCOPE
K905083 · Baxter Healthcare Corp · Jun 1991