LYK · Class II · 21 CFR 876.1500

FDA Product Code LYK: Angioscope

Leading manufacturers include Applied Medical Resources, American Edwards Laboratories and Intertherapy, 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 Nov 30, 2006
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
K062340
Cardio-Optics, Inc.
Cardiovascular · 112d
Cleared Jul 28, 2005
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
K050808
Cardio-Optics, Inc.
Cardiovascular · 120d
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 28, 1995
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
K952638
Baxter Edwards
Cardiovascular · 49d
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 04, 1994
ULTATHIN FLEXIBLE ENDOSCOPE
K941715
Technology Marketing Group
Cardiovascular · 180d
Cleared Jan 18, 1994
ANGIOSCOPE
K934696
Intramed Laboratories, Inc.
Cardiovascular · 110d
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 Jun 16, 1993
DISPOSABLE STEERABLE ANGIOSCOPE
K931421
Endovascular, Inc.
Cardiovascular · 86d
Cleared Mar 23, 1993
4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45
K926433
Baxter Edwards
Cardiovascular · 90d
Cleared Feb 25, 1993
CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE
K924554
Clarus Medical Systems, Inc.
Cardiovascular · 169d
Cleared Jan 13, 1993
DISPOSABLE VASCULAR ANGIOSCOPE
K923996
Endovascular, Inc.
Cardiovascular · 156d
Cleared Apr 23, 1992
AMETEC MASY MODULAR ANGIOSCOPE SYSTEM
K905745
American Medical Technology, Inc.
Cardiovascular · 486d
Cleared Jan 27, 1992
DISPOSABLE VASCULAR ANGIOSCOPE
K914570
Nobles-Lai
Cardiovascular · 104d
Cleared Dec 27, 1991
ANGIOLAZ ANGIOSCOPE CATHETER
K913129
Angiolaz, Inc.
Cardiovascular · 164d
Cleared Nov 20, 1991
INTERPRET(TM) CATHETER LINEAR TRANSLATOR
K913763
Intertherapy, Inc.
Cardiovascular · 90d
Cleared Jul 31, 1991
OMEGA ANGIOSCOPES (OMEGASCOPES)
K911090
Omega Universal Technologies, Ltd.
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 →