Catheter Research C/O Burditt, Bowles & Radzius: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Catheter Research C/O Burditt, Bowles & Radzius” (first 1987, latest 1993), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 184 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 |
|---|---|---|---|
| DRA | Catheter, Steerable | 4 | 4 |
| DXX | System, Catheter Control, Steerable | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DSS | Clip, Vascular | 1 | 1 |
Review panels
- Cardiovascular (8)
Most recent Catheter Research C/O Burditt, Bowles & Radzius 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924227 | CRI CYNOSAR CATHETER | DRA | 1993-06-29 | 312 |
| K924125 | CRI ELECTRONIC CONTROL SYSTEM | DXX | 1993-05-26 | 282 |
| K914523 | CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL | DSS | 1992-01-10 | 92 |
| K904785 | CRI CYNOSAR CATHETER | DRA | 1991-03-06 | 135 |
| K904787 | CRI STEERABLE CATHETER CONTROL SYSTEM | DXX | 1990-12-17 | 55 |
| K900320 | CRI CYNOSAR CATHETER | DRA | 1990-09-14 | 234 |
| K884337 | MICRO-GUIDE SYSTEM | DRA | 1989-01-05 | 83 |
| K870700 | MICRO-GUIDE | DQO | 1987-12-03 | 287 |
Recalls
openFDA lists no recalls under a recalling firm named Catheter Research C/O Burditt, Bowles & Radzius.
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 Innovations, Inc. (8 510(k)s)
- Catheter Research, Inc. (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 Research C/O Burditt, Bowles & Radzius?
FDA lists 8 510(k) clearances under the applicant name “Catheter Research C/O Burditt, Bowles & Radzius” (first 1987, latest 1993), 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 Research C/O Burditt, Bowles & Radzius?
The median time from FDA receipt to decision across 510(k)s cleared under the name Catheter Research C/O Burditt, Bowles & Radzius is 184 days.
Which FDA product codes appear under Catheter Research C/O Burditt, Bowles & Radzius?
The most frequent FDA product codes under this applicant name are DRA (Catheter, Steerable, 4); DXX (System, Catheter Control, Steerable, 2); DQO (Catheter, Intravascular, Diagnostic, 1).
Next steps
- See all 8 Catheter Research C/O Burditt, Bowles & Radzius clearances with predicates and recalls
- Run predicate analysis for product code DRA, Catheter Research C/O Burditt, Bowles & Radzius'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.