Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bard Peripheral Vascular, Inc. — Predicate Candidate Screening
34 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
184 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260012 | UltraScore™ Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2026-02-04 | 30 | 0 |
| K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025-12-12 | 109 | 0 |
| K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Ki | Bard Peripheral Vascular, Inc. | 2025-07-10 | 184 | 0 |
| K250219 | Dorado™ PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2025-06-17 | 144 | 0 |
| K243642 | UltraCor™ Twirl™ Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2025-03-24 | 118 | 0 |
| K242757 | Rotarex Atherectomy System | Bard Peripheral Vascular, Inc. | 2025-01-30 | 140 | 1 |
| K241946 | PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit ( | Bard Peripheral Vascular, Inc. | 2024-12-06 | 156 | 0 |
| K232737 | PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; Powe | Bard Peripheral Vascular, Inc. | 2023-12-08 | 92 | 0 |
| K221440 | Liverty™ TIPS Access Set | Bard Peripheral Vascular, Inc. | 2022-05-31 | 14 | 0 |
| K211410 | GlidePath 13F Long-Term Hemodialysis Catheter | Bard Peripheral Vascular, Inc. | 2021-06-04 | 29 | 0 |
| K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Prob | Bard Peripheral Vascular, Inc. | 2019-11-07 | 20 | 0 |
| K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | Bard Peripheral Vascular, Inc. | 2019-10-03 | 38 | 0 |
| K180061 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2018-03-09 | 60 | 0 |
| K171953 | Bard Mission Disposable Core Biopsy Instrument | Bard Peripheral Vascular, Inc. | 2017-09-14 | 77 | 3 |
| K163420 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2017-06-14 | 190 | 0 |
| K161986 | SIDEKICK and USHER Support Catheters | Bard Peripheral Vascular, Inc. | 2016-08-04 | 16 | 0 |
| K152510 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2016-05-13 | 254 | 0 |
| K142261 | Ultraverse 035 PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2014-09-24 | 41 | 0 |
| K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R | Bard Peripheral Vascular, Inc. | 2014-02-21 | 60 | 4 |
| K133569 | TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 C | Bard Peripheral Vascular, Inc. | 2013-12-20 | 30 | 0 |
| K131199 | ULTRAVERSE RX PTA BALLOON DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2013-05-30 | 34 | 0 |
| K120722 | RIVAL PTA DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2012-04-19 | 41 | 0 |
| K120971 | ATLAS PTA BALLOON DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2012-04-19 | 17 | 0 |
| K120660 | CONQUEST 40 PTA DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2012-03-15 | 10 | 0 |
| K103367 | SEEKER CROSSING SUPPORT CATHETER | Bard Peripheral Vascular, Inc. | 2010-12-08 | 22 | 2 |
| K063532 | BARD E LUMINEXX BILIARY STENT | Bard Peripheral Vascular, Inc. | 2008-05-30 | 555 | 17 |
| K072283 | DORADO PTA BALLOON DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2007-09-19 | 34 | 15 |
| K052578 | BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MOD | Bard Peripheral Vascular, Inc. | 2005-11-25 | 66 | 2 |
| K052282 | VENAFLO II VASCULAR GRAFT | Bard Peripheral Vascular, Inc. | 2005-09-20 | 29 | 0 |
| K052114 | BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP | Bard Peripheral Vascular, Inc. | 2005-08-25 | 21 | 0 |
| K052236 | BARD ATLAS PTA BALLOON DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2005-08-23 | 6 | 0 |
| K050832 | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT | Bard Peripheral Vascular, Inc. | 2005-07-07 | 97 | 0 |
| K050049 | DYNAFLO BYPASS GRAFT | Bard Peripheral Vascular, Inc. | 2005-01-31 | 21 | 0 |
| K042062 | PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE | Bard Peripheral Vascular, Inc. | 2004-09-30 | 59 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda