FDA 510(k) Applications Submitted by REBECCA P PINE

FDA 510(k) Number Submission Date Device Name Applicant
K101479 05/28/2010 WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL
K140066 01/10/2014 INFILL CERVICAL PINNACLE SPINE GROUP, LLC
K140104 01/15/2014 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL
K120178 01/20/2012 WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL
K160272 02/02/2016 Endophys Pressure Sensing Sheath Kit Endophys, Inc.
K190393 02/19/2019 Wingman 14C Crossing Catheter ReFlow Medical, Inc.
K130518 02/27/2013 MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER LUTHER NEEDLESAFE PRODUCTS, INC.
K160848 03/28/2016 Wingman 18 Crossing Catheter ReFlow Medical, Inc.
K151184 05/04/2015 InFill Interbody Fusion Devices PINNACLE SPINE GROUP, LLC
K121476 05/18/2012 INFILL GRAFT DELIVERY SYSTEM PINNACLE SPINE GROUP, LLC
K131475 05/22/2013 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL
K141504 06/06/2014 T-8000 THEROZONE UNIT THEROZONE USA, INC.
K141547 06/11/2014 WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL
K121733 06/13/2012 INFILL INTERVERTEBRAL BODY FUSION DEVICE PINNACLE SPINE GROUP, LLC
K141649 06/20/2014 SPEX SUPPORT CATHETER REFLOW MEDICAL
K151880 07/09/2015 Wingman Crossing Catheter REFLOW MEDICAL
K062026 07/18/2006 VAP-NT CHOLESTEROL TEST ATHEROTECH, INC.
K192083 08/02/2019 Okami Medical LOBO Vascular Occlusion System Okami Medical
K132420 08/05/2013 WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL
K132482 08/08/2013 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL
K162237 08/09/2016 XO1 Knee Balancing System XPANDORTHO, INC.
K152259 08/11/2015 InFill Interbody Fusion Device Pinnacle Spine Group, LLC
K212544 08/12/2021 MiniLoad Syringe OcuJect, LLC
K202432 08/25/2020 MiniLoad Syringe OcuJect, LLC
K142513 09/08/2014 Barricade Embolization Coil System BLOCKADE MEDICAL
K102683 09/17/2010 THE ADDITION OB THE-ADDITION, LLC
K123338 10/31/2012 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL
K183016 10/31/2018 SteriCap Mini Needle OcuJet, LLC
K113263 11/04/2011 ARGES IMAGING CONTRAST SPRAY ARGES IMAGING, INC
K123398 11/05/2012 DR. SCHOLL'S COMPRESSION SOCKS RENFRO CORPORATION
K173661 11/29/2017 Wingman 35 Crossing Catheter ReFlow Medical, Inc.
K173662 11/29/2017 speX Support Catheter ReFlow Medical, Inc.
K133721 12/05/2013 INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 PINNACLE SPINE GROUP, LLC
K143488 12/08/2014 InFill Graft Delivery System PINNACLE SPINE GROUP, LLC
K103729 12/22/2010 INFILL INTERVERTEBRAL BODY FUSION DEVICE PINNACLE SPINE GROUP, LLC
K124012 12/27/2012 INFILL OBLIQUE TLIF DEVICE PINNACLE SPINE GROUP, LLC
K111632 06/13/2011 INFILL GRAFT DELIVERY SYSTEM PINNACLE SPINE GROUP, LLC
DEN170004 01/10/2017 Ellipsys Vascular Access System Avenu Medical, Inc
K150206 01/29/2015 InFill Interbody Fusion Devices PINNACLE SPINE GROUP, LLC
K170768 03/14/2017 Mini Needle OcuJect, LLC
K170996 04/03/2017 Wingman 14C Crossing Catheter ReFlow Medical, Inc.
K160945 04/05/2016 Endophys Blood Pressure Monitor ENDOPHYS HOLDINGS, LLC
K151571 06/10/2015 Mini Needle OCUJET, LLC
K151760 06/29/2015 Barricade Embolization Coil System BLOCKADE MEDICAL
K181725 06/29/2018 Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) Avenu Medical, Inc.
K172390 08/08/2017 Optima Coil System Blockade Medical, LLC (d.b.a. Balt USA)
K212805 09/02/2021 SteriCap Mini Needle and Standard Needles OcuJect, LLC
K173711 12/04/2017 Wallaby Avenir Coil System Wallaby Medical, Inc.
K150484 02/24/2015 Penguin In-Line Warmer Creche Innovations


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