Medical Device Manufacturer · US , Tempe , AZ

Bard Peripheral Vascular, Inc.

34 submissions · 30 cleared · Since 2004
34
Total
30
Cleared
0
Denied

Bard Peripheral Vascular, Inc. — FDA 510(k) Submissions

Bard Peripheral Vascular, Inc. has submitted 34 FDA 510(k) premarket notifications since 2004, of which 30 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Angioplasty, Peripheral, Transluminal, Instrument, Biopsy, Catheter, Percutaneous, Marker, Radiographic, Implantable, Catheter, Percutaneous, Cutting/scoring . Use the specialty filter in the sidebar to narrow results.

34 devices
1–25 of 34
UltraScore? Focused Force PTA Balloon
K260012 · PNO Catheter, Percutaneous,... · Cardiovascular
Feb 2026 30d
EnCor EnCompass? Breast Biopsy and Tissue Removal System
K252681 · KNW Instrument, Biopsy · General & Plastic Surgery
Dec 2025 109d
Marquee? Disposable Core Biopsy Instrument and Instrument Kit
K250032 · KNW Instrument, Biopsy · General & Plastic Surgery
Jul 2025 184d
Dorado? PTA Balloon Dilatation Catheter
K250219 · DQY Catheter, Percutaneous · Cardiovascular
Jun 2025 144d
UltraCor? Twirl? Breast Tissue Marker
K243642 · NEU Marker, Radiographic,... · General & Plastic Surgery
Mar 2025 118d
Rotarex Atherectomy System
K242757 · MCW Catheter, Peripheral,... · Cardiovascular
Jan 2025 140d
PeritX? 1L Drainage Kit (90-1010); PeritX? 2L Drainage Kit (90-2010); PeritX? Peritoneal Catheter Kit (50-9000C); PeritX? Peritoneal Catheter and Starter Kit (50-9900C); PeritX? Peritoneal Catheter Mini Kit (50-9050A); PleurX? Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX? Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX? Supplemental Insertion Kit (50-7262); Procedure Pack (50-
K241946 · PNG Peritoneal, Drainage... · Gastroenterology & Urology
Dec 2024 156d
PowerPort? ClearVUE? Slim ECG Enabled Implantable Port; PowerPort? ClearVUE? isp ECG Enabled Implantable Port; PowerPort? isp M.R.I.? ECG Enabled Implantable Port; PowerPort? Slim ECG Enabled Implantable Port
K232737 · LJT Port & Catheter,... · General Hospital
Dec 2023 92d
Liverty? TIPS Access Set
K221440 · DYB Introducer, Catheter · Cardiovascular
May 2022 14d
GlidePath 13F Long-Term Hemodialysis Catheter
K211410 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Jun 2021 29d
EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
K192948 · KNW Instrument, Biopsy · General & Plastic Surgery
Nov 2019 20d
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
K192318 · LIT Catheter, Angioplasty,... · Cardiovascular
Oct 2019 38d
UltraCor Twirl Breast Tissue Marker
K180061 · NEU Marker, Radiographic,... · General & Plastic Surgery
Mar 2018 60d
Bard Mission Disposable Core Biopsy Instrument
K171953 · KNW Instrument, Biopsy · Gastroenterology & Urology
Sep 2017 77d
UltraScore Focused Force PTA Balloon
K163420 · PNO Catheter, Percutaneous,... · Cardiovascular
Jun 2017 190d
SIDEKICK and USHER Support Catheters
K161986 · DQY Catheter, Percutaneous · Cardiovascular
Aug 2016 16d
UltraCor Twirl Breast Tissue Marker
K152510 · NEU Marker, Radiographic,... · General & Plastic Surgery
May 2016 254d
Ultraverse 035 PTA Balloon Dilatation Catheter
K142261 · LIT Catheter, Angioplasty,... · Cardiovascular
Sep 2014 41d
BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
K133948 · KNW Instrument, Biopsy · Gastroenterology & Urology
Feb 2014 60d
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
K133569 · OZT Balloon Aortic Valvuloplasty · Cardiovascular
Dec 2013 30d
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
K131199 · LIT Catheter, Angioplasty,... · Cardiovascular
May 2013 34d
RIVAL PTA DILATATION CATHETER
K120722 · LIT Catheter, Angioplasty,... · Cardiovascular
Apr 2012 41d
ATLAS PTA BALLOON DILATATION CATHETER
K120971 · LIT Catheter, Angioplasty,... · Cardiovascular
Apr 2012 17d
CONQUEST 40 PTA DILATATION CATHETER
K120660 · LIT Catheter, Angioplasty,... · Cardiovascular
Mar 2012 10d
SEEKER CROSSING SUPPORT CATHETER
K103367 · DQY Catheter, Percutaneous · Cardiovascular
Dec 2010 22d
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