LYK · Class II · 21 CFR 876.1500

FDA Product Code LYK: Angioscope

Leading manufacturers include American Edwards Laboratories, Applied Medical Resources and KARL STORZ Endoscopy-America, Inc..

41
Total
41
Cleared
155d
Avg days
1983
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 85d recently vs 159d historically

FDA 510(k) Cleared Angioscope Devices (Product Code LYK)

41 devices
1–24 of 41
Cleared Jan 28, 2026
Vena MicroAngioscope™ System
K253842
Vena Medical Holdings Corp
Cardiovascular · 57d
Cleared Oct 01, 2025
Vena MicroAngioscope™ System
K251767
Vena Medical Holdings Corp
Cardiovascular · 113d
Cleared Apr 17, 2002
KSEA FIBERSCOPE
K011793
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 313d
Cleared Nov 08, 2001
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Oct 30, 2000
KSEA VASCULAR FIBERSCOPES
K001408
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 179d
Cleared Feb 20, 1997
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
K964061
W.L. Gore & Associates, Inc.
Cardiovascular · 133d
Cleared Jul 11, 1995
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE
K951721
Applied Medical Resources
Cardiovascular · 88d
Cleared Feb 10, 1995
APPLIED MEDICAL OPTICAL VALVULOTOME
K945591
Applied Medical Resources
Cardiovascular · 88d
Cleared Oct 18, 1993
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
K931464
Baxter Healthcare Corp
Cardiovascular · 208d
Cleared Sep 24, 1993
DIAGNOSTIC INTRAVASCULAR CATHETER
K930758
Applied Medical Resources
Cardiovascular · 224d
Cleared Jul 17, 1991
OLYMPUS AF ANGIOSCOPE SYSTEM
K911278
Olympus Corp.
Cardiovascular · 114d
Cleared Jun 21, 1991
4.5F IMAGECATH ANGIOSCOPE
K905083
Baxter Healthcare Corp
Cardiovascular · 220d
Cleared Apr 26, 1990
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
K895538
Trimedyne, Inc.
Cardiovascular · 225d
Cleared Sep 28, 1988
ACS ANGIOSCOPE GUIDE WIRE
K883000
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 72d
Cleared Sep 27, 1988
ACS CORONARY ANGIOSCOPIC CATHETER
K875108
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 288d
Cleared Nov 20, 1986
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
K860858
Olympus Corp.
Cardiovascular · 258d
Cleared Oct 18, 1984
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE
K842481
American Edwards Laboratories
Cardiovascular · 115d
Cleared Jun 11, 1984
ANGIOSCOPY CATHETER
K834547
American Edwards Laboratories
Cardiovascular · 167d
Cleared Nov 03, 1983
ANGIOSCOPY CATHETER
K832698
American Edwards Laboratories
Cardiovascular · 85d
Cleared Jun 02, 1983
ANGIOSCOPE
K830084
Trimedyne, Inc.
Cardiovascular · 142d

About Product Code LYK - Regulatory Context

510(k) Submission Activity

41 total 510(k) submissions under product code LYK since 1983, with 41 receiving FDA clearance (average review time: 155 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LYK Product Code

Recent submissions under LYK have taken an average of 85 days to reach a decision - down from 159 days historically, suggesting improved FDA processing for this classification.

LYK devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →