FDA 510(k), INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054, INSTRUMED INTERNATIONAL, INC.

510(K) Number: K100518
Device Name: INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
Manufacturer: INSTRUMED INTERNATIONAL, INC.
Device Classification Name: Dilator, Vessel, Surgical
Regulation Number: 870.4475
Classification Product Code: DWP
Date Received: 02/23/2010
Decision Date: 08/31/2010
Regulation Medical Specialty: Cardiovascular