Hansen Medical, Inc.: FDA clearances and approvals
Hansen Medical, Inc. has 17 FDA 510(k) clearances (first 2006, latest 2016), across 4 product codes in 1 review panel. Median 510(k) review time: 81 days. openFDA lists 5 product recalls by a recalling firm named Hansen Medical, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 222 |
| 2013 | 1 | 59 |
| 2014 | 2 | 66 |
| 2015 | 3 | 78 |
| 2016 | 2 | 123 |
| 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 | 10 | 10 |
| DRA | Catheter, Steerable | 5 | 5 |
| DRC | Trocar | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
Review panels
- Cardiovascular (17)
Most recent Hansen Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | DRA | 2016-09-20 | 169 |
| K153304 | Hansen Medical Magellan Robotic Catheter eKit | DRA | 2016-02-01 | 77 |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | DRA | 2015-08-18 | 78 |
| K151730 | Magellan Robotic System | DXX | 2015-07-23 | 27 |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | DXX | 2015-07-01 | 233 |
| K141614 | MAGELLAN ROBOTIC SYSTEM | DXX | 2014-08-07 | 52 |
| K133552 | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT | DRA | 2014-02-07 | 80 |
| K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | DXX | 2013-09-27 | 59 |
| K122275 | ARTISAN EXTEND CONTROL CATHETER | DRA | 2012-08-29 | 30 |
| K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER | DXX | 2012-05-29 | 414 |
7 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2016-03-25.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hansen Medical, Inc. have?
Hansen Medical, Inc. has 17 FDA 510(k) clearances (first 2006, latest 2016), across 4 product codes in 1 review panel.
How long does FDA take to clear Hansen Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hansen Medical, Inc.'s cleared 510(k)s is 81 days.
What devices does Hansen Medical, Inc. make?
Its most frequent FDA product codes are DXX (System, Catheter Control, Steerable, 10); DRA (Catheter, Steerable, 5); DRC (Trocar, 1).
Has Hansen Medical, Inc. had device recalls?
openFDA lists 5 product recalls in 5 recall events by a recalling firm whose name matches Hansen Medical, Inc; the most recent began 2016-03-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 17 Hansen Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXX, Hansen Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.