FDA 510(k) Applications Submitted by BARD PERIPHERAL VASCULAR, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K242757 09/12/2024 Rotarex Atherectomy System Bard Peripheral Vascular, Inc.
K192318 08/26/2019 Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Bard Peripheral Vascular, Inc.
K120660 03/05/2012 CONQUEST 40 PTA DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC.
K103367 11/16/2010 SEEKER CROSSING SUPPORT CATHETER BARD PERIPHERAL VASCULAR, INC.
K050832 04/01/2005 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT BARD PERIPHERAL VASCULAR, INC.
K052114 08/04/2005 BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP BARD PERIPHERAL VASCULAR, INC.
K072283 08/16/2007 DORADO PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC.
K052236 08/17/2005 BARD ATLAS PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC.
K052578 09/20/2005 BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J BARD PERIPHERAL VASCULAR, INC.
K050049 01/10/2005 DYNAFLO BYPASS GRAFT BARD PERIPHERAL VASCULAR, INC.
K052282 08/22/2005 VENAFLO II VASCULAR GRAFT BARD PERIPHERAL VASCULAR, INC.
K250219 01/24/2025 DoradoÖ PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc.
K152510 09/02/2015 UltraCor Twirl Breast Tissue Marker BARD PERIPHERAL VASCULAR, INC.
K232737 09/07/2023 PowerPortÖ ClearVUEÖ Slim ECG Enabled Implantable Port; PowerPortÖ ClearVUEÖ isp ECG Enabled Implantable Port; PowerPortÖ isp M.R.I.Ö ECG Enabled Implantable Port; PowerPortÖ Slim ECG Enabled Implantable Port Bard Peripheral Vascular, Inc.
K063532 11/22/2006 BARD E LUMINEXX BILIARY STENT BARD PERIPHERAL VASCULAR, INC.
K131199 04/26/2013 ULTRAVERSE RX PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC.
K142261 08/14/2014 Ultraverse 035 PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc.
K120722 03/09/2012 RIVAL PTA DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC.
K120971 04/02/2012 ATLAS PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC.
K180061 01/08/2018 UltraCor Twirl Breast Tissue Marker Bard Peripheral Vascular, Inc.
K192948 10/18/2019 EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G Bard Peripheral Vascular, Inc.
K243642 11/26/2024 UltraCorÖ TwirlÖ Breast Tissue Marker Bard Peripheral Vascular, Inc.
K161986 07/19/2016 SIDEKICK and USHER Support Catheters BARD PERIPHERAL VASCULAR, INC.
K250032 01/07/2025 MarqueeÖ Disposable Core Biopsy Instrument and Instrument Kit Bard Peripheral Vascular, Inc.
K133948 12/23/2013 BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT BARD PERIPHERAL VASCULAR, INC.
K042062 08/02/2004 PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE BARD PERIPHERAL VASCULAR, INC.
K171953 06/29/2017 Bard Mission Disposable Core Biopsy Instrument Bard Peripheral Vascular, Inc.
K133569 11/20/2013 TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM BARD PERIPHERAL VASCULAR, INC.
K163420 12/06/2016 UltraScore Focused Force PTA Balloon BARD PERIPHERAL VASCULAR, INC.


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