Bard Peripheral Vascular, Inc.: FDA clearances and approvals
Bard Peripheral Vascular, Inc. has 39 FDA 510(k) clearances (first 2003, latest 2026), plus 6 PMA decisions, across 21 product codes in 5 review panels. Median 510(k) review time: 41 days. Since 2017 its median was 84 days, against 108 days for all cleared 510(k)s in the same product codes. openFDA lists 237 product recalls by a recalling firm named Bard Peripheral Vascular, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 17 |
| 2013 | 2 | 32 |
| 2014 | 2 | 50 |
| 2015 | 0 | — |
| 2016 | 2 | 135 |
| 2017 | 2 | 134 |
| 2018 | 1 | 60 |
| 2019 | 2 | 29 |
| 2020 | 0 | — |
| 2021 | 2 | 26 |
| 2022 | 2 | 60 |
| 2023 | 1 | 92 |
| 2024 | 1 | 156 |
| 2025 | 5 | 140 |
| 2026 | 2 | 26 |
Review time against the same product codes
Since 2017, Bard Peripheral Vascular, Inc.'s cleared 510(k)s took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNW | Instrument, Biopsy | 8 | 8 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 6 | 6 |
| DQY | Catheter, Percutaneous | 5 | 5 |
| NEU | Marker, Radiographic, Implantable | 3 | 3 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 2 | 2 |
| DTK | Filter, Intravascular, Cardiovascular | 2 | 2 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| JCT | Prosthesis, Tracheal, Expandable | 2 | 2 |
| PFV | System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment | 2 | 0 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 2 | 2 |
Plus 11 more product codes.
Review panels
- Cardiovascular (26)
- General and Plastic Surgery (11)
- Gastroenterology and Urology (4)
- Anesthesiology (2)
- General Hospital (2)
Most recent Bard Peripheral Vascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal System | KNW | 2026-08-14 | 21 |
| K260012 | UltraScore Focused Force PTA Balloon | PNO | 2026-02-04 | 30 |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System | KNW | 2025-12-12 | 109 |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit | KNW | 2025-07-10 | 184 |
| K250219 | Dorado PTA Balloon Dilatation Catheter | DQY | 2025-06-17 | 144 |
| K243642 | UltraCor Twirl Breast Tissue Marker | NEU | 2025-03-24 | 118 |
| K242757 | Rotarex Atherectomy System | MCW | 2025-01-30 | 140 |
| K241946 | 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- | PNG | 2024-12-06 | 156 |
| K232737 | 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 | LJT | 2023-12-08 | 92 |
| K221440 | Liverty TIPS Access Set | DYB | 2022-05-31 | 14 |
29 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180037 | PMA | Venovo Venous Stent System | 2019-03-13 |
| P160024 | PMA | LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT | 2017-04-24 |
| P130029 | PMA | FLUENCY PLUS ENDOVASCULAR STENT GRAFT | 2014-06-17 |
| P070014 | PMA | LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM | 2009-02-13 |
| P080007 | PMA | BARD E-LUMINEXX VASCULAR STENT | 2008-12-04 |
Recalls
237 product recalls in 69 recall events; 28 initiated in the last five years. Most recent: 2026-08-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Bard Peripheral Vascular, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Bard Peripheral Vascular, Inc. have?
Bard Peripheral Vascular, Inc. has 39 FDA 510(k) clearances (first 2003, latest 2026), plus 6 PMA decisions, across 21 product codes in 5 review panels.
How long does FDA take to clear Bard Peripheral Vascular, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bard Peripheral Vascular, Inc.'s cleared 510(k)s is 41 days. Since 2017: 84 days, versus 108 days for all cleared 510(k)s in the same product codes.
What devices does Bard Peripheral Vascular, Inc. make?
Its most frequent FDA product codes are KNW (Instrument, Biopsy, 8); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 6); DQY (Catheter, Percutaneous, 5).
Has Bard Peripheral Vascular, Inc. had device recalls?
openFDA lists 237 product recalls in 69 recall events by a recalling firm whose name matches Bard Peripheral Vascular, Inc; the most recent began 2026-08-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 39 Bard Peripheral Vascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Bard Peripheral Vascular, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.