Cleared Traditional

K905745 - AMETEC MASY MODULAR ANGIOSCOPE SYSTEM

K905745 is the FDA 510(k) clearance for AMETEC MASY MODULAR ANGIOSCOPE SYSTEM by American Medical Technology, Inc.. It is a Class 2 Cardiovascular device (product code LYK) cleared through the Traditional 510(k) pathway after a 486-day FDA review.

K905745 · American Medical Technology, Inc. · Cardiovascular device
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Apr 1992
Decision
486d
Days
Class 2
Risk

K905745 is an FDA 510(k) clearance for the AMETEC MASY MODULAR ANGIOSCOPE SYSTEM. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by American Medical Technology, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 23, 1992 after a review of 486 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all American Medical Technology, Inc. devices

Submission Details

510(k) Number K905745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1990
Decision Date April 23, 1992
Days to Decision 486 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
361d slower than avg
Panel avg: 125d · This submission: 486d
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 15
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K905745.
KSEA VASCULAR FIBERSCOPES
K001408 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
K964061 · W.L. Gore & Associates, Inc. · Feb 1997
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
K931464 · Baxter Healthcare Corp · Oct 1993
OLYMPUS AF ANGIOSCOPE SYSTEM
K911278 · Olympus Corp. · Jul 1991
4.5F IMAGECATH ANGIOSCOPE
K905083 · Baxter Healthcare Corp · Jun 1991
ACS ANGIOSCOPE GUIDE WIRE
K883000 · Advanced Cardiovascular Systems, Inc. · Sep 1988