Cormed, Inc., Sub. C.R.Bard, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cormed, Inc., Sub. C.R.Bard, Inc.” (first 1983, latest 1986), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under BD (Becton, Dickinson and Company), based on public ownership records.
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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | 2 |
| DYB | Introducer, Catheter | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
Review panels
Most recent Cormed, Inc., Sub. C.R.Bard, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863606 | BUTTERFLY NON-CORING NEEDLE SET | FMI | 1986-12-18 | 93 |
| K860432 | PERCUTANEOUS INTRODUCER KIT | DYB | 1986-03-31 | 55 |
| K854019 | PORT-GARD | LJT | 1985-11-26 | 57 |
| K850967 | STERILE CORMED MEDIPORT | LJT | 1985-05-17 | 70 |
| K850674 | CORMED II AMBULATORY INFUSION PUMP | FRN | 1985-04-09 | 48 |
| K843083 | CORMED HUBER POINT NEEDLE | GAA | 1984-09-05 | 30 |
| K833915 | VASCULAR ACCESS CATH. REPAIR KIT | LJS | 1984-03-30 | 137 |
| K823553 | CORCATH H & B VASCULAR ACCESS CATHETER | LJS | 1983-01-05 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Cormed, Inc., Sub. C.R.Bard, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Cormed, Inc., Sub. C.R.Bard, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cormed, Inc., Sub. C.R.Bard, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Cormed, Inc., Sub. C.R.Bard, Inc.” (first 1983, latest 1986), across 6 product codes in 3 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 Cormed, Inc., Sub. C.R.Bard, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cormed, Inc., Sub. C.R.Bard, Inc. is 56 days.
Which FDA product codes appear under Cormed, Inc., Sub. C.R.Bard, Inc.?
The most frequent FDA product codes under this applicant name are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 2); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 2); DYB (Introducer, Catheter, 1).
Next steps
- See all 8 Cormed, Inc., Sub. C.R.Bard, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJS, Cormed, Inc., Sub. C.R.Bard, 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.