Catheter Robotics, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Catheter Robotics, Inc.” (first 2012, latest 2012), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 142 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 | 2 | 142 |
| 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 |
|---|---|---|---|
| DXX | System, Catheter Control, Steerable | 2 | 2 |
| PJB | Catheter Remote Control System | 1 | 0 |
Review panels
- Cardiovascular (3)
Most recent Catheter Robotics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122488 | AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES | DXX | 2012-11-20 | 97 |
| K113628 | AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES | DXX | 2012-06-12 | 187 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140009 | De Novo | Catheter Remote Control System | 2014-12-18 |
Recalls
openFDA lists no recalls under a recalling firm named Catheter Robotics, 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.
Device clinical trials
An industry sponsor named Catheter Robotics, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01139814: Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies (Completed, started 2010-06)
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 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 Precision, Inc. (2 510(k)s)
- Catheter Sciences Co. (2 510(k)s)
- Catheter Corp. of America (1 510(k)s)
- The Catheter Exchange, Inc. (1 510(k)s)
- Catheter, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Catheter Robotics, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Catheter Robotics, Inc.” (first 2012, latest 2012), plus 1 De Novo decision, 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 Catheter Robotics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Catheter Robotics, Inc. is 142 days.
Which FDA product codes appear under Catheter Robotics, Inc.?
The most frequent FDA product codes under this applicant name are DXX (System, Catheter Control, Steerable, 2); PJB (Catheter Remote Control System, 1).
Next steps
- See all 2 Catheter Robotics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXX, Catheter Robotics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.