FDA 510(k) Applications for Medical Device Product Code "LYK"
(Angioscope)

FDA 510(k) Number Applicant Device Name Decision Date
K062340 CARDIO-OPTICS, INC. CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM 11/30/2006
K050808 CARDIO-OPTICS, INC. CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 07/28/2005
K011793 KARL STORZ ENDOSCOPY-AMERICA, INC. KSEA FIBERSCOPE 04/17/2002
K001408 KARL STORZ ENDOSCOPY-AMERICA, INC. KSEA VASCULAR FIBERSCOPES 10/30/2000
K012724 SMITH & NEPHEW, INC. SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 11/08/2001
K964061 W.L. GORE & ASSOCIATES,INC GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) 02/20/1997


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