# Bard Peripheral Vascular, Inc.

- Location (FDA's records): Tempe, AZ
- FDA decisions: 46 (2003–2026): 39 510(k) clearances and 7 original PMA approvals
- Names in FDA's records: Bard Peripheral Vascular, Inc. (41); Bard Peripheral Vascular (5)
- Product codes: KNW (8), LIT (6), DQY (5), NEU (3), FGE (2), PNO (2), DTK (2), JCT (2), DSY (2), PFV (2), NIO (1), KCT (1)
- 510(k) review time since 2016: median 60 days, against 99 for FDA's reviews in the same codes and years (12 of 17 faster)
- Predicates its devices cite: 48 (13 its own); citations of its devices by later devices: 56 (13 its own)
- Recalls linked to its devices: 54 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C.R. Bard, Inc.: 20 (https://510kreport.com/company/cr-bard)
- C. R. Bard: 2 (https://510kreport.com/company/c-r-bard)
- Vidacare Corporation: 2 (https://510kreport.com/company/vidacare)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Impra, Inc.: 2 (https://510kreport.com/company/impra)
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)
- Mermaid Medical A/S: 1 (https://510kreport.com/company/mermaid-medical-a-s)
- Loma Vista Medical: 1 (https://510kreport.com/company/loma-vista-medical)

## Firms that cite its devices most
- C.R. Bard, Inc.: 13 (https://510kreport.com/company/cr-bard)
- KANEKA Corporation: 3 (https://510kreport.com/company/kaneka)
- Idev Technologies, Inc.: 3 (https://510kreport.com/company/idev-technologies)
- Tayside Flow Technologies Limited: 2 (https://510kreport.com/company/tayside-flow-technologies)
- Zhejiang Curaway Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/zhejiang-curaway-medical-technology)
- Canyon Medical, Inc.: 2 (https://510kreport.com/company/canyon-medical)
- Merit Medical Systems, Inc.: 2 (https://510kreport.com/company/merit-medical-systems)
- Carbon (Shenzhen) Medical Device Co., Ltd.: 1 (https://510kreport.com/company/carbon-shenzhen-medical-device)

## Its most-cited devices
- K133948: Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument (2014), cited by 13
- K072283: Dorado Pta Balloon Dilatation Catheter (2007), cited by 7
- K131199: Ultraverse RX Pta Balloon Dilatation Catheter (2013), cited by 5
- K171953: Bard Mission Disposable Core Biopsy Instrument (2017), cited by 4
- K063532: Bard E Luminexx Biliary Stent (2008), cited by 4
- K133569: True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM (2013), cited by 3

## Recent decisions
- P250050: Liverty™ TIPS Stent Graft (Sep 25, 2026)
- K262571: EnCor EnCompass™ Breast Biopsy and Tissue Removal System (Aug 14, 2026)
- K260012: UltraScore™ Focused Force PTA Balloon (Feb 4, 2026)
- K252681: EnCor EnCompass™ Breast Biopsy and Tissue Removal System (Dec 12, 2025)
- K250032: Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (Jul 10, 2025)
- K250219: Dorado™ PTA Balloon Dilatation Catheter (Jun 17, 2025)
- K243642: UltraCor™ Twirl™ Breast Tissue Marker (Mar 24, 2025)
- K242757: Rotarex Atherectomy System (Jan 30, 2025)

Source page: https://510kreport.com/company/bard-peripheral-vascular