510(k) K141614
- Device
- MAGELLAN ROBOTIC SYSTEM
- Applicant
- Hansen Medical
- 510(k) number
- K141614
- Product code
- DXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-08-07
- Date received
- 2014-06-16
- Regulation
- 870.1290
- Classification name
- System, Catheter Control, Steerable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATE W LEE
- Address
- 800 E Middlefield Rd. Mountain View CA US 94043 94043
FDA Registration Numbers#
- 2246552
- 3003084417
- 2953359
- 3017403339
- 3008627763
- 2011171
Source Documents#
Other 510(k) Records For Product Code DXX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251792 | Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) | Stereotaxis, Inc. | 2025-11-06 |
| K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS) | Microbot Medical , Ltd. | 2025-09-04 |
| K221464 | CorPath GRX System | Corindus, Inc. | 2022-07-27 |
| K202275 | CorPath GRX System | Corindus, Inc. | 2020-12-11 |
| K180517 | CorPath GRX System | Corindus, Inc. | 2018-03-29 |
| K173806 | CorPath GRX System | Corindus, Inc. | 2018-03-01 |
| K173288 | CorPath GRX System | Corindus, Inc. | 2018-02-15 |
| K160121 | CorPath GRX System | Corindus, Inc. | 2016-10-27 |
| K152999 | CorPath 200 System | Corindus, Inc. | 2016-03-18 |
| K150892 | CorPath 200 System | Corindus, Inc. | 2015-10-02 |
| K151730 | Magellan Robotic System | Hansen Medical, Inc. | 2015-07-23 |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | Hansen Medical, Inc. | 2015-07-01 |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Stereotaxis, Inc. | 2015-06-17 |
| K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | Stereotaxis, Inc. | 2014-12-18 |
| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | Stereotaxis, Inc. | 2014-09-03 |
Legacy Summary#
summary
FDA Review#
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