Cleared Traditional

K905083 - 4.5F IMAGECATH ANGIOSCOPE

K905083 is an FDA 510(k) clearance for 4.5F IMAGECATH ANGIOSCOPE, manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code LYK cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K905083 · Baxter Healthcare Corp · Cardiovascular device
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Jun 1991
Decision
220d
Days
Class 2
Risk

K905083 is an FDA 510(k) clearance for the 4.5F IMAGECATH ANGIOSCOPE. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on June 21, 1991 after a review of 220 days - an extended review 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: 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 Healthcare Corp devices

FDA 510(k) Submission Details - K905083

510(k) Number K905083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1990
Decision Date June 21, 1991
Days to Decision 220 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 125d · This submission: 220d
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 23
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K905083.
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
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