Catheter Technology Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Catheter Technology Corp.” (first 1983, latest 1988), across 10 product codes in 6 review panels. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| FOS | Catheter, Umbilical Artery | 1 | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | 1 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 | 1 |
| LKS | Device, Parasite Concentration | 1 | 1 |
Review panels
- General Hospital (6)
- Clinical Chemistry (2)
- Microbiology (2)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- Immunology (1)
Most recent Catheter Technology Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880571 | CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM | LJT | 1988-03-04 | 23 |
| K871080 | PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | DQY | 1987-08-12 | 147 |
| K871998 | GROSHONG CV CATHETER REPAIR KIT | LJS | 1987-06-24 | 29 |
| K860256 | BRAWN AND GROSHONG CATHETERS | FOZ | 1986-03-28 | 63 |
| K842577 | CATH-TECH POLYURETHANE UMBILICAL VESS | FOZ | 1985-03-13 | 253 |
| K842147 | CATH-TECH CHOLANGIOGRAPHY CATHETER | FGE | 1984-10-02 | 125 |
| K840339 | UMBILICAL VESSEL CATHETER | FOS | 1984-07-25 | 182 |
| K831386 | GROSHONG CATHETER, LONG TERM TYPE | LJS | 1983-10-14 | 169 |
| K831366 | TESTCORP PREG | JHJ | 1983-06-02 | 37 |
| K831365 | TESTCORP ANA | LKS | 1983-06-02 | 37 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Catheter Technology Corp..
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.
- Catheter Innovations, Inc. (8 510(k)s)
- Catheter Research, Inc. (8 510(k)s)
- Catheter Research C/O Burditt, Bowles & Radzius (8 510(k)s)
- Catheter Connections, Inc. (7 510(k)s)
- Catheter Robotics, Inc. (2 510(k)s)
- Catheter Precision, Inc. (2 510(k)s)
- Catheter Sciences Co. (2 510(k)s)
- Catheter, LLC (1 510(k)s)
- Catheter Corp. of America (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Catheter Technology Corp.?
FDA lists 13 510(k) clearances under the applicant name “Catheter Technology Corp.” (first 1983, latest 1988), across 10 product codes in 6 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 Catheter Technology Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Catheter Technology Corp. is 37 days.
Which FDA product codes appear under Catheter Technology Corp.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); JHJ (Agglutination Method, Human Chorionic Gonadotropin, 2); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 2).
Next steps
- See all 13 Catheter Technology Corp. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Catheter Technology 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.