Cordis Europa, N.V.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cordis Europa, N.V.” (first 2001, latest 2007), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| KNQ | Dilator, Esophageal | 2 | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
Review panels
Most recent Cordis Europa, N.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071189 | CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER | LIT | 2007-05-16 | 16 |
| K063563 | CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER | LIT | 2007-03-07 | 99 |
| K060302 | INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED | KNQ | 2006-04-11 | 64 |
| K043605 | INSCOPE 3-STAGE BALLOON DILATOR | KNQ | 2005-02-04 | 36 |
| K040413 | CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM | FGE | 2004-06-21 | 124 |
| K032737 | CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA | DQY | 2003-10-02 | 28 |
| K012056 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM | FGE | 2001-08-01 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Cordis Europa, N.V..
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 Corp., A Johnson & Johnson Co. (5 510(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 Europa, N.V.?
FDA lists 7 510(k) clearances under the applicant name “Cordis Europa, N.V.” (first 2001, latest 2007), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cordis Europa, N.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cordis Europa, N.V. is 36 days.
Which FDA product codes appear under Cordis Europa, N.V.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 2); KNQ (Dilator, Esophageal, 2); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 2).
Next steps
- See all 7 Cordis Europa, N.V. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Cordis Europa, N.V.'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.