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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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