Cardima, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Cardima, Inc.” (first 1993, latest 2006), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 233 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 |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 5 | 5 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
Review panels
- Cardiovascular (12)
Most recent Cardima, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060715 | MODIFICATION TO: CARDIMA ABLATION SYSTEM | OCL | 2006-05-15 | 59 |
| K022008 | CARDIMA ABLATION SYSTEM | OCL | 2003-01-29 | 224 |
| K974683 | NAVIPORT DEFLECTABLE TIP GUIDING CATHETER | DQY | 1999-06-22 | 553 |
| K972803 | TRACER O-T-W MAPPING DEVICE | DRF | 1999-05-11 | 652 |
| K982835 | ELECTRODE SWITCHBOX, MODEL 11-081002 | DRF | 1998-10-29 | 78 |
| K971975 | CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER | DRF | 1998-07-01 | 398 |
| K973298 | CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER | DQY | 1998-06-26 | 297 |
| K970853 | PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) | DRF | 1997-11-04 | 242 |
| K955802 | PATHFINDER | DRF | 1997-01-29 | 404 |
| K951603 | CARDIMA, INC. FORERUNNER | DQY | 1995-10-05 | 181 |
2 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-05-20.
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 Cardima, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Cardima, Inc.” (first 1993, latest 2006), across 5 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 Cardima, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardima, Inc. is 233 days.
Which FDA product codes appear under Cardima, Inc.?
The most frequent FDA product codes under this applicant name are DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 5); DQY (Catheter, Percutaneous, 3); OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue, 2).
Next steps
- See all 12 Cardima, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRF, Cardima, 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.