Cordis Webster, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Cordis Webster, Inc.” (first 1995, latest 1999), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 8 | 8 |
| DYB | Introducer, Catheter | 2 | 2 |
Review panels
- Cardiovascular (10)
Most recent Cordis Webster, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | DRF | 1999-11-26 | 85 |
| K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | DRF | 1999-10-04 | 154 |
| K982740 | CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S | DYB | 1998-08-28 | 22 |
| K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | DRF | 1998-08-10 | 28 |
| K980961 | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. | DRF | 1998-05-28 | 73 |
| K970264 | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM | DYB | 1997-10-28 | 278 |
| K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | 1996-09-18 | 408 |
| K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | DRF | 1996-03-25 | 90 |
| K954390 | CORDIS WESTER STAR CATHETER | DRF | 1995-12-21 | 93 |
| K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | 1995-11-22 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Cordis Webster, Inc..
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 Europa, N.V. (7 510(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 Webster, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Cordis Webster, Inc.” (first 1995, latest 1999), across 2 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 Webster, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cordis Webster, Inc. is 92 days.
Which FDA product codes appear under Cordis Webster, Inc.?
The most frequent FDA product codes under this applicant name are DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 8); DYB (Introducer, Catheter, 2).
Next steps
- See all 10 Cordis Webster, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRF, Cordis Webster, Inc.'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.