FDA applicant
Bard Peripheral Vascular, Inc.
FDA records 46 decisions for Bard Peripheral Vascular, Inc. (Tempe, AZ) from 2003 to 2026: 39 510(k) clearances and 7 original PMA approvals. Most are in product codes KNW (Instrument, Biopsy) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 48 predicates, 13 of them its own earlier devices. 54 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Bard Peripheral Vascular”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bard Peripheral Vascular, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Bard Peripheral Vascular, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Bard”
FDA records each applicant name separately; these may or may not be the same firm.