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FDA 510(k) Applications Submitted by LEO L BASTA
FDA 510(k) Number
Submission Date
Device Name
Applicant
K120018
01/03/2012
MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
MINDCHILD MEDICAL
K180194
01/24/2018
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
Paragonix Technologies, Inc.
K110752
03/18/2011
HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
HIGHLAND INSTRUMENTS
K140932
04/11/2014
AMSEL OCCLUDER DEVICE
AMSEL MEDICAL CORPORATION
K101218
04/30/2010
PATCHASSIST
POLYTOUCH MEDICAL LTD
K971673
05/07/1997
40 CC SUMO
BOSTON SCIENTIFIC CORP.
K081410
05/20/2008
OPTION VENA CAVA FILTER
REX MEDICAL
K972113
06/05/1997
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
BOSTON SCIENTIFIC CORP.
K132545
08/13/2013
MEDIVALVE ACWIRE
MEDIVALVE LTD.
K963187
08/14/1996
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
BOSTON SCIENTIFIC CORP.
K132698
08/29/2013
FASTOUCH FIXATION SYSTEM
VIA SURGICAL LTD.
K954431
09/25/1995
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
BOSTON SCIENTIFIC CORP.
K123326
10/26/2012
SHERPA PAK CARDIAC TRANSPORT SYSTEM
PARAGONIX TECHNOLOGIES, INC.
K103269
11/04/2010
PATCHASSIST LARGE
POLYTOUCH MEDICAL LTD
K133432
11/05/2013
SHERPA PAK CARDIAC TRANSPORT SYSTEM
PARAGONIX TECHNOLOGIES, INC.
K974247
11/12/1997
40 CC GRANDE
BOSTON SCIENTIFIC CORP.
K133694
12/03/2013
SHERPA PAK TRANSPORTER
PARAGONIX TECHNOLOGIES, INC.
K081956
07/09/2008
MEDINOL X-SUIT NIR BILIARY METALLIC STENT
MEDINOL LTD.
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