Cleared Traditional

K952638 - 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[

K952638 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 49-day FDA review.

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

FDA 510(k) Submission Details - K952638

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.

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 K952638.
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · Smith & Nephew, Inc. · Nov 2001
KSEA VASCULAR FIBERSCOPES
K001408 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
K964061 · W.L. Gore & Associates, Inc. · Feb 1997
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE
K951721 · Applied Medical Resources · Jul 1995
APPLIED MEDICAL OPTICAL VALVULOTOME
K945591 · Applied Medical Resources · Feb 1995
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
K931464 · Baxter Healthcare Corp · Oct 1993