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LYK — Angioscope Class II

FDA Device Classification

Classification Details

Product Code
LYK
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
CV
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253842vena medical holdingsVena MicroAngioscope™ SystemJanuary 28, 2026
K251767vena medical holdingsVena MicroAngioscope™ SystemOctober 1, 2025
K062340cardio-opticsCARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEMNovember 30, 2006
K050808cardio-opticsCORONARY SINUS ACCESS KIT, MODEL KCS8F-01July 28, 2005
K011793karl storz endoscopy-americaKSEA FIBERSCOPEApril 17, 2002
K012724smith and nephewSMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273November 8, 2001
K001408karl storz endoscopy-americaKSEA VASCULAR FIBERSCOPESOctober 30, 2000
K964061w.l. gore and associatesGORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)February 20, 1997
K952638baxter edwards4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THEJuly 28, 1995
K951721applied medical resourcesAPPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPEJuly 11, 1995
K945591applied medical resourcesAPPLIED MEDICAL OPTICAL VALVULOTOMEFebruary 10, 1995
K941715technology marketing groupULTATHIN FLEXIBLE ENDOSCOPEOctober 4, 1994
K934696intramed laboratoriesANGIOSCOPEJanuary 18, 1994
K931464baxter healthcareBAXTER CORONARY ANGIOSCOPE INFLATION DEVICEOctober 18, 1993
K930758applied medical resourcesDIAGNOSTIC INTRAVASCULAR CATHETERSeptember 24, 1993
K931421endovascularDISPOSABLE STEERABLE ANGIOSCOPEJune 16, 1993
K926433baxter edwards4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45March 23, 1993
K924554clarus medical systemsCLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPEFebruary 25, 1993
K923996endovascularDISPOSABLE VASCULAR ANGIOSCOPEJanuary 13, 1993
K905745american medical technologyAMETEC MASY MODULAR ANGIOSCOPE SYSTEMApril 23, 1992