Cordis Corp., A Johnson & Johnson Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cordis Corp., A Johnson & Johnson Co.” (first 2006, latest 2014), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 29 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 29 |
| 2014 | 1 | 266 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DTK | Filter, Intravascular, Cardiovascular | 1 | 1 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Cordis Corp., A Johnson & Johnson Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140438 | MICRO GUIDE CATHETER ELITE | PDU | 2014-11-14 | 266 |
| K131225 | ADROIT GUIDING CATHETER | DQY | 2013-05-29 | 29 |
| K091077 | OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER | DTK | 2010-02-04 | 296 |
| K083814 | OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 | PDU | 2009-01-13 | 22 |
| K062531 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | NTE | 2006-09-22 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Cordis Corp., A Johnson & Johnson Co..
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.
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 US Corporation (4 510(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 Corp., A Johnson & Johnson Co.?
FDA lists 5 510(k) clearances under the applicant name “Cordis Corp., A Johnson & Johnson Co.” (first 2006, latest 2014), across 4 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 Corp., A Johnson & Johnson Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cordis Corp., A Johnson & Johnson Co. is 29 days.
Which FDA product codes appear under Cordis Corp., A Johnson & Johnson Co.?
The most frequent FDA product codes under this applicant name are PDU (Catheter For Crossing Total Occlusions, 2); DQY (Catheter, Percutaneous, 1); DTK (Filter, Intravascular, Cardiovascular, 1).
Next steps
- See all 5 Cordis Corp., A Johnson & Johnson Co. clearances with predicates and recalls
- Run predicate analysis for product code PDU, Cordis Corp., A Johnson & Johnson Co.'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.