Catheter Innovations, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Catheter Innovations, Inc.” (first 1998, latest 2002), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 20 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 3 | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Catheter Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021704 | VAXCEL PICC WITH PASV VALVE TECHNOLOGY | LJS | 2002-06-06 | 14 |
| K010349 | DUAL LUMEN MIDLINE CATHETER | LJS | 2001-02-28 | 23 |
| K003642 | PLACEMENT-PLUS | LJS | 2000-12-20 | 23 |
| K993860 | CATHETER INNOVATIONS IMPLANTABLE PORT | LJT | 1999-12-03 | 18 |
| K991897 | CATHETER INNOVATIONS IMPLANTABLE PORT | LJT | 1999-10-21 | 139 |
| K981382 | PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS | FOZ | 1998-05-01 | 15 |
| K981368 | PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS | FOZ | 1998-05-01 | 16 |
| K980127 | 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT | FPA | 1998-03-11 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Catheter Innovations, 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.
- Catheter Technology Corp. (13 510(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 Innovations, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Catheter Innovations, Inc.” (first 1998, latest 2002), across 4 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 Catheter Innovations, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Catheter Innovations, Inc. is 20 days.
Which FDA product codes appear under Catheter Innovations, Inc.?
The most frequent FDA product codes under this applicant name are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 3); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 2).
Next steps
- See all 8 Catheter Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJS, Catheter Innovations, 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.