510(k) K001408

KSEA VASCULAR FIBERSCOPES by KARL STORZ Endoscopy-America, Inc. — Product Code LYK

K001408 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA VASCULAR FIBERSCOPES". The FDA issued a decision of Substantially Equivalent on October 30, 2000. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.