Cordis Corp.: FDA filings under this applicant name
FDA lists 328 510(k) clearances under the applicant name “Cordis Corp.” (first 1976, latest 2022), plus 6 PMA decisions, across 80 product codes in 11 review panels. Median 510(k) review time under this name: 68 days. Since 2017 the median was 106 days, against 123 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 |
|---|---|---|
| 2012 | 2 | 126 |
| 2013 | 0 | — |
| 2014 | 2 | 264 |
| 2015 | 1 | 47 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 78 |
| 2019 | 0 | — |
| 2020 | 2 | 126 |
| 2021 | 2 | 130 |
| 2022 | 2 | 92 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cordis Corp. took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 38 | 38 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 30 | 30 |
| DQO | Catheter, Intravascular, Diagnostic | 29 | 29 |
| DQX | Wire, Guide, Catheter | 25 | 25 |
| DQY | Catheter, Percutaneous | 22 | 22 |
| DYB | Introducer, Catheter | 22 | 22 |
| DXY | Implantable Pacemaker Pulse-Generator | 21 | 21 |
| JXG | Shunt, Central Nervous System And Components | 18 | 18 |
| DTB | Permanent Pacemaker Electrode | 13 | 13 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 8 | 8 |
Plus 70 more product codes.
Review panels
- Cardiovascular (209)
- Gastroenterology and Urology (61)
- Neurology (29)
- Microbiology (12)
- General Hospital (8)
- Immunology (5)
- General and Plastic Surgery (3)
- Clinical Chemistry (2)
- Hematology (2)
- Clinical Toxicology (2)
- Anesthesiology (1)
Most recent Cordis Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | NTE | 2022-04-06 | 30 |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | DQO | 2022-02-17 | 153 |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | LIT | 2021-04-23 | 52 |
| K202167 | Brite Tip Radianz Guiding Sheath | DYB | 2021-02-26 | 207 |
| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter | LIT | 2020-10-09 | 136 |
| K201333 | SABER .035 PTA Dilatation Catheter | LIT | 2020-09-11 | 115 |
| K181592 | RAIN Sheath Transradial | DYB | 2018-08-15 | 58 |
| K180081 | RAILWAY Sheathless Access System | DYB | 2018-04-18 | 97 |
| K143412 | ADROIT Guiding Catheter | DQY | 2015-01-14 | 47 |
| K133843 | SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER | LIT | 2014-06-27 | 191 |
318 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P020026 | PMA | CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER | 2003-04-24 |
| P990036 | PMA | CORDIS CHECKMATE(TM) SYSTEM | 2000-11-03 |
| P900043 | PMA | PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT | 1994-08-02 |
| P890032 | PMA | CORDIS STEERABLE PTCA BALLOON CATHETER | 1990-03-06 |
| P880003 | PMA | CORDIS PTCA DILATATION CATHETER | 1988-10-28 |
Recalls
147 product recalls in 46 recall events; 6 initiated in the last five years. Most recent: 2021-10-01.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Cordis Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)
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 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 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.?
FDA lists 328 510(k) clearances under the applicant name “Cordis Corp.” (first 1976, latest 2022), plus 6 PMA decisions, across 80 product codes in 11 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 Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cordis Corp. is 68 days. Since 2017: 106 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cordis Corp.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 38); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 30); DQO (Catheter, Intravascular, Diagnostic, 29).
Next steps
- See all 328 Cordis Corp. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Cordis Corp.'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.