510(k) K832795

HEIFETZ INTRACRANIAL ANEURYSM CLIPS by Edward Weck, Inc. — Product Code HCH

K832795 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "HEIFETZ INTRACRANIAL ANEURYSM CLIPS". The FDA issued a decision of Substantially Equivalent on November 25, 1983. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.