510(k) K841514

SCANLAN VASCU-STATT II APPROXIMATOR by Scanlan Intl., Inc. — Product Code HRQ

K841514 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "SCANLAN VASCU-STATT II APPROXIMATOR". The FDA issued a decision of Substantially Equivalent on June 5, 1984. The device falls under product code HRQ (Hemostat), a Class I device regulated under 21 CFR 878.4800. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.