Product Code: LYK FDA class 2 21 CFR 876.1500

Angioscope

Gastroenterology, Urology

The Angioscope (product code LYK) is a minimally invasive cardiovascular instrument consisting of a flexible fiberoptic endoscope used to directly visualize the interior of blood vessels, enabling assessment of vascular lesions, thrombi, and valve function. Regulated under 21 CFR 876.1500 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the Gastroenterology/Urology specialty with review by the Cardiovascular (CV) panel. It is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LYK
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: CV
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 41 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253842	Vena MicroAngioscope System	Jan 28, 2026	Substantially Equivalent	Vena Medical Holdings Corp
K251767	Vena MicroAngioscope System	Oct 01, 2025	Substantially Equivalent	Vena Medical Holdings Corp
K062340	CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM	Nov 30, 2006	Substantially Equivalent	Cardio-Optics, Inc.
K050808	CORONARY SINUS ACCESS KIT, MODEL KCS8F-01	Jul 28, 2005	Substantially Equivalent	Cardio-Optics, Inc.
K011793	KSEA FIBERSCOPE	Apr 17, 2002	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K012724	SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273	Nov 08, 2001	Substantially Equivalent	Smith & Nephew, Inc.
K001408	KSEA VASCULAR FIBERSCOPES	Oct 30, 2000	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K964061	GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)	Feb 20, 1997	Substantially Equivalent	W. L. Gore & Associates, Inc.
K952638	4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[	Jul 28, 1995	Substantially Equivalent	Baxter Edwards
K951721	APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE	Jul 11, 1995	Substantially Equivalent	Applied Medical Resources
K945591	APPLIED MEDICAL OPTICAL VALVULOTOME	Feb 10, 1995	Substantially Equivalent	Applied Medical Resources
K941715	ULTATHIN FLEXIBLE ENDOSCOPE	Oct 04, 1994	Substantially Equivalent	Technology Marketing Group
K934696	ANGIOSCOPE	Jan 18, 1994	Substantially Equivalent	Intramed Laboratories, Inc.
K931464	BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE	Oct 18, 1993	Substantially Equivalent	Baxter Healthcare Corp
K930758	DIAGNOSTIC INTRAVASCULAR CATHETER	Sep 24, 1993	Substantially Equivalent	Applied Medical Resources
K931421	DISPOSABLE STEERABLE ANGIOSCOPE	Jun 16, 1993	Substantially Equivalent	Endovascular, Inc.
K926433	4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45	Mar 23, 1993	Substantially Equivalent	Baxter Edwards
K924554	CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE	Feb 25, 1993	Substantially Equivalent	Clarus Medical Systems, Inc.
K923996	DISPOSABLE VASCULAR ANGIOSCOPE	Jan 13, 1993	Substantially Equivalent	Endovascular, Inc.
K905745	AMETEC MASY MODULAR ANGIOSCOPE SYSTEM	Apr 23, 1992	Substantially Equivalent	American Medical Technology, Inc.
K914570	DISPOSABLE VASCULAR ANGIOSCOPE	Jan 27, 1992	Substantially Equivalent	Nobles-Lai
K913129	ANGIOLAZ ANGIOSCOPE CATHETER	Dec 27, 1991	Substantially Equivalent	Angiolaz, Inc.
K913763	INTERPRET(TM) CATHETER LINEAR TRANSLATOR	Nov 20, 1991	Substantially Equivalent	Intertherapy, Inc.
K911090	OMEGA ANGIOSCOPES (OMEGASCOPES)	Jul 31, 1991	Substantially Equivalent	Omega Universal Technologies, Ltd.
K911278	OLYMPUS AF ANGIOSCOPE SYSTEM	Jul 17, 1991	Substantially Equivalent	Olympus Corp.
K905083	4.5F IMAGECATH ANGIOSCOPE	Jun 21, 1991	Substantially Equivalent	Baxter Healthcare Corp
K902329	ULTRA-VU ANGIOSCOPE	Aug 22, 1990	Substantially Equivalent	Angiolaz, Inc.
K895538	ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY	Apr 26, 1990	Substantially Equivalent	Trimedyne, Inc.
K900305	INTRAVASCULAR IMAGING SYSTEMS	Apr 20, 1990	Substantially Equivalent	Intertherapy, Inc.
K897153	CVIS INSIGHT IMAGING CATHETER	Mar 26, 1990	Substantially Equivalent	Cardiovascular Imaging Systems, Inc.
K895159	INTRAVASCULAR IMAGING SYSTEM	Mar 12, 1990	Substantially Equivalent	Intertherapy, Inc.
K894459	ANGIOSCOPE	Mar 07, 1990	Substantially Equivalent	Intramed Laboratories, Inc.
K893816	HEMOLASER HEMOSCOPE	Feb 01, 1990	Substantially Equivalent	Hemolaser Corp.
K890047	VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM	Jun 20, 1989	Substantially Equivalent	Vascucare, Inc.
K883000	ACS ANGIOSCOPE GUIDE WIRE	Sep 28, 1988	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K875108	ACS CORONARY ANGIOSCOPIC CATHETER	Sep 27, 1988	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K860858	OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE	Nov 20, 1986	Substantially Equivalent	Olympus Corp.
K842481	AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE	Oct 18, 1984	Substantially Equivalent	American Edwards Laboratories
K834547	ANGIOSCOPY CATHETER	Jun 11, 1984	Substantially Equivalent	American Edwards Laboratories
K832698	ANGIOSCOPY CATHETER	Nov 03, 1983	Substantially Equivalent	American Edwards Laboratories
K830084	ANGIOSCOPE	Jun 02, 1983	Substantially Equivalent	Trimedyne, Inc.