Cleared Traditional

4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ (K952638) - FDA 510(k) Clearance

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

K952638 · Baxter Edwards · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
49d
Days
Class 2
Risk

K952638 is an FDA 510(k) clearance for the 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS .... Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Baxter Edwards (Santa Ana, US). The FDA issued a Cleared decision on July 28, 1995 after a review of 49 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 Baxter Edwards devices

Submission Details

510(k) Number K952638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1995
Decision Date July 28, 1995
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 K952638.
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