FDA applicant
Cordis Corp., A Johnson & Johnson Co.
FDA records 11 decisions for Cordis Corp., A Johnson & Johnson Co. (Fremont, CA) from 1999 to 2015: 11 510(k) clearances. Most are in product codes PDU (Catheter For Crossing Total Occlusions) and DTK (Filter, Intravascular, Cardiovascular). Its devices cite 17 predicates, 3 of them its own earlier devices. 3 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Cordis, A Johnson & Johnson Co.”, “Cordis Corporation, A Johnson & Johnson Co.”, “Cordis Corporation, A Johnson & Johnson Company”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cordis Corp., A Johnson & Johnson Co.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2015
2026 so far, outlined.
Recalls per year
3in 2013
Class I Class II/III not classified
Planning a device like Cordis Corp., A Johnson & Johnson Co.’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 “Cordis”
FDA records each applicant name separately; these may or may not be the same firm.