Cordis US Corporation: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Cordis US Corporation” (first 2022, latest 2024), plus 8 PMA decisions, across 11 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Since 2017 the median was 74 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 60 |
| 2023 | 2 | 64 |
| 2024 | 1 | 228 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cordis US Corporation took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MGB | Device, Hemostasis, Vascular | 2 | 0 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 1 | 0 |
| NIM | Stent, Carotid | 1 | 0 |
| NIN | Stent, Renal | 1 | 0 |
| NIO | Stent, Iliac | 1 | 0 |
| NIP | Stent, Superficial Femoral Artery | 1 | 0 |
Plus 1 more product codes.
Review panels
- Cardiovascular (12)
Most recent Cordis US Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233637 | Cordis BRITECROSS Support Catheter | DQY | 2024-06-28 | 228 |
| K232573 | INFINITI Ambi Angiographic Catheter | DQO | 2023-11-21 | 88 |
| K230704 | RAIN Sheath Tibial Pedal Introducer | DYB | 2023-04-24 | 41 |
| K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | LIT | 2022-08-22 | 60 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220004 | PMA | PALMAZ MULLINS XD Pulmonary Stent | 2023-07-21 |
| P150002 | PMA | INCRAFT(R) AAA STENT GRAFT SYSTEM | 2018-11-27 |
| P120002 | PMA | SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS | 2012-11-07 |
| P100013 | PMA | CORDIS EXOSEAL VASCULAR CLOSURE DEVICE | 2011-05-19 |
| P030047 | PMA | CORDIS PRECISE NITINOL STENT SYSTEM | 2006-09-22 |
Recalls
22 product recalls in 7 recall events; 22 initiated in the last five years. Most recent: 2025-03-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Cordis US Corporation is the lead sponsor of 62 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07246902: Mobilization and Outcomes After Venous Closure (Recruiting, started 2025-11-24)
- NCT07204678: PMCF Study of Precise Pro Rx for Carotid Artery Disease (Completed, started 2025-10-30)
- NCT05554471: Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression (Completed, started 2022-08-30)
- NCT05399680: Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access (Completed, started 2022-06-29)
- NCT05543096: PMCF Study for Cardiology Access Procedures (Completed, started 2022-05-23)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cordis Corp. (328 510(k)s)
- Cordis Neurovascular, Inc. (38 510(k)s)
- Cordis Webster, Inc. (10 510(k)s)
- Cordis Europa, N.V. (7 510(k)s)
- Cordis Corp., A Johnson & Johnson Co. (5 510(k)s)
- Cordis, A Johnson & Johnson Co. (4 510(k)s)
- Cordis Leads, Inc. (4 510(k)s)
- Cordis, A Cardinal Health Company (1 510(k)s)
- Cordis Corporation, A Johnson & Johnson Co. (1 510(k)s)
- Cordis Corporation, A Johnson & Johnson Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cordis US Corporation?
FDA lists 4 510(k) clearances under the applicant name “Cordis US Corporation” (first 2022, latest 2024), plus 8 PMA decisions, across 11 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cordis US Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cordis US Corporation is 74 days. Since 2017: 74 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cordis US Corporation?
The most frequent FDA product codes under this applicant name are MGB (Device, Hemostasis, Vascular, 2); DQO (Catheter, Intravascular, Diagnostic, 1); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 4 Cordis US Corporation clearances with predicates and recalls
- Run predicate analysis for product code MGB, Cordis US Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.