FDA applicant
Ostial Corporation
FDA records 12 decisions for Ostial Corporation (Mountain View, CA) from 2011 to 2016: 12 510(k) clearances. Most are in product codes LIT (Catheter, Angioplasty, Peripheral, Transluminal) and LOX (Catheters, Transluminal Coronary Angioplasty…). Its devices cite 19 predicates, 15 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ostial Corporation’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Ostial Corporation’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 “Ostial”
FDA records each applicant name separately; these may or may not be the same firm.