Advanced Catheter Systems: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Advanced Catheter Systems” (first 1982, latest 1982), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 4 | 4 |
| DYG | Catheter, Flow Directed | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Advanced Catheter Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K813577 | PRESSURE INDICATOR-REGULATOR | DQO | 1982-01-29 | 37 |
| K813624 | ADVANCED CATHETER SYSTEMS CORONARY GUID | DQO | 1982-01-22 | 24 |
| K813623 | SIMPSON-ROBERT CORONARY GUIDING CATHET | DQO | 1982-01-22 | 24 |
| K813622 | INDEFLATOR | DQO | 1982-01-22 | 24 |
| K813578 | HEMOSTATIC SIDE-ARM ADAPTER | DYG | 1982-01-18 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Catheter Systems.
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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Catheter Systems?
FDA lists 5 510(k) clearances under the applicant name “Advanced Catheter Systems” (first 1982, latest 1982), 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 Advanced Catheter Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Catheter Systems is 24 days.
Which FDA product codes appear under Advanced Catheter Systems?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 4); DYG (Catheter, Flow Directed, 1).
Next steps
- See all 5 Advanced Catheter Systems clearances with predicates and recalls
- Run predicate analysis for product code DQO, Advanced Catheter Systems'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.