FDA 510(k) Applications Submitted by Matthew D. Stepanek

FDA 510(k) Number Submission Date Device Name Applicant
K132474 08/07/2013 CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER ACIST MEDICAL SYSTEMS
K112842 09/29/2011 AMS ELEVATE PC AMERICAN MEDICAL SYSTEMS, INC.
K191060 04/22/2019 ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit ACIST Medical Systems, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact