Cleared Traditional

K900305 - INTRAVASCULAR IMAGING SYSTEMS

K900305 is an FDA 510(k) clearance for INTRAVASCULAR IMAGING SYSTEMS, manufactured by Intertherapy, Inc.. The device is a Class 2 Cardiovascular device with product code LYK cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K900305 · Intertherapy, Inc. · Cardiovascular device
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Apr 1990
Decision
89d
Days
Class 2
Risk

K900305 is an FDA 510(k) clearance for the INTRAVASCULAR IMAGING SYSTEMS. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Intertherapy, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on April 20, 1990 after a review of 89 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 Intertherapy, Inc. devices

FDA 510(k) Submission Details - K900305

510(k) Number K900305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1990
Decision Date April 20, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
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 24
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K900305.
OLYMPUS AF ANGIOSCOPE SYSTEM
K911278 · Olympus Corp. · Jul 1991
4.5F IMAGECATH ANGIOSCOPE
K905083 · Baxter Healthcare Corp · Jun 1991
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
K895538 · Trimedyne, Inc. · Apr 1990
CVIS INSIGHT IMAGING CATHETER
K897153 · Cardiovascular Imaging Systems, Inc. · Mar 1990
ACS ANGIOSCOPE GUIDE WIRE
K883000 · Advanced Cardiovascular Systems, Inc. · Sep 1988
ACS CORONARY ANGIOSCOPIC CATHETER
K875108 · Advanced Cardiovascular Systems, Inc. · Sep 1988