FDA applicant
Abbott Vascular
FDA records 64 decisions for Abbott Vascular (Santa Clara, CA) from 1986 to 2022: 50 510(k) clearances and 14 original PMA approvals. Most are in product codes DQX (Wire, Guide, Catheter) and LOX (Catheters, Transluminal Coronary Angioplasty…). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 86 predicates, 27 of them its own earlier devices. 9 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Abbott Vascular, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Abbott Vascular’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Abbott Vascular’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 “Abbott”
FDA records each applicant name separately; these may or may not be the same firm.