FDA 510(k) Applications Submitted by Holly Ramirez

FDA 510(k) Number Submission Date Device Name Applicant
K220501 02/22/2022 Pounce Thrombectomy System Surmodics Inc.
K211044 04/08/2021 Sublime Radial Access 018 RX Dilatation Catheter Creagh Medical Ltd. (a wholly owned subsidiary of Surmodics,
K231022 04/10/2023 PounceÖ Thrombectomy System Surmodics Inc.
K111252 05/03/2011 ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F BOSTON SCIENTIFIC CORP.
K211492 05/13/2021 Pounce Thrombectomy System Surmodics, Inc.
K121694 06/07/2012 IMAGER II ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC CORP.
K221886 06/29/2022 Sublime Microcatheter Surmodics Inc.
K132914 09/17/2013 ACUITY PRO LEAD DELIVERY SYSTEM BOSTON SCIENTIFIC
K123765 12/07/2012 GUIDEZILLA GUIDE EXTENSION CATHETER BOSTON SCIENTIFIC


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