Cleared Traditional

K913129 - ANGIOLAZ ANGIOSCOPE CATHETER

K913129 is an FDA 510(k) clearance for ANGIOLAZ ANGIOSCOPE CATHETER, manufactured by Angiolaz, Inc.. The device is a Class 2 Cardiovascular device with product code LYK cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K913129 · Angiolaz, Inc. · Cardiovascular device
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Dec 1991
Decision
164d
Days
Class 2
Risk

K913129 is an FDA 510(k) clearance for the ANGIOLAZ ANGIOSCOPE CATHETER. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Angiolaz, Inc. (Rockingham, US). The FDA issued a Cleared decision on December 27, 1991 after a review of 164 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 Angiolaz, Inc. devices

FDA 510(k) Submission Details - K913129

510(k) Number K913129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1991
Decision Date December 27, 1991
Days to Decision 164 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 125d · This submission: 164d
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 20
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K913129.
APPLIED MEDICAL OPTICAL VALVULOTOME
K945591 · Applied Medical Resources · Feb 1995
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
K931464 · Baxter Healthcare Corp · Oct 1993
DIAGNOSTIC INTRAVASCULAR CATHETER
K930758 · Applied Medical Resources · Sep 1993
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