Endocardial Solutions, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Endocardial Solutions, Inc.” (first 1999, latest 2004), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 5 | 5 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 2 | 2 |
| DRB | Stylet, Catheter | 1 | 1 |
Review panels
- Cardiovascular (8)
Most recent Endocardial Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042493 | ENSITE SYSTEM, MODEL EE3000 | DQK | 2004-10-15 | 31 |
| K033211 | ENSITE SYSTEM | DQK | 2003-10-30 | 27 |
| K030129 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 | DQK | 2003-04-22 | 98 |
| K012926 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 | MTD | 2001-09-28 | 28 |
| K001437 | ENSITE 3000 SYSTEM, MODEL EE3000 | DQK | 2000-06-07 | 30 |
| K993376 | ENSTYLET MODELS EC0010, EC0020 | DRB | 2000-01-05 | 90 |
| K992479 | ENSITE 3000 SYSTEM | DQK | 1999-12-02 | 129 |
| K983456 | ENSITE 3000 SYSTEM | MTD | 1999-04-21 | 203 |
Recalls
openFDA lists no recalls under a recalling firm named Endocardial Solutions, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Endocardial Solutions, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Endocardial Solutions, Inc.” (first 1999, latest 2004), across 3 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 Endocardial Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endocardial Solutions, Inc. is 60 days.
Which FDA product codes appear under Endocardial Solutions, Inc.?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 5); MTD (Catheter, Intracardiac Mapping, High-Density Array, 2); DRB (Stylet, Catheter, 1).
Next steps
- See all 8 Endocardial Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQK, Endocardial Solutions, 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.