Home › Device types › DXX
System, Catheter Control, Steerable
FDA product code DXX · Class 2 · Cardiovascular
43
Registered devices
86
Adverse events
4
Recalls
33
510(k) clearances
Devices with this code
Vdrive Drape — Stereotaxis, Inc.Magellan™ — HANSEN MEDICAL, INC.Artisan® — HANSEN MEDICAL, INC.Magellan™ — HANSEN MEDICAL, INC.CorPath GRX Extended Reach Arm — Corindus, Inc.CorPath GRX Control Console — Corindus, Inc.V-CAS Catheter Advancement System — Stereotaxis, Inc.CorPath GRX Cassette Duo — Corindus, Inc.CorPath GRX Drape, Control Console — Corindus, Inc.CorPath GRX Cassette — Corindus, Inc.CorPath 200 Control Console — Corindus, Inc.CorPath 200 POGO Pin Caps — Corindus, Inc.V-Loop Variable Loop Catheter Manipulator — Stereotaxis, Inc.GenesisX — Stereotaxis, Inc.Magellan™ — HANSEN MEDICAL, INC.CorPath GRX Robotic Drive — Corindus, Inc.LIBERTY Endovascular Robotic System - robot — MICROBOT MEDICAL LTDCorPath 200 Joystick Covers — Corindus, Inc.Vdrive System — Stereotaxis, Inc.Magellan™ — HANSEN MEDICAL, INC.Magellan™ — HANSEN MEDICAL, INC.CorPath 200 Robotic Drive Drape — Corindus, Inc.Magellan™ — HANSEN MEDICAL, INC.CorPath GRX Drive Gear — Corindus, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-03-25 | Hansen Medical Inc | Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy. |
| 2015-03-18 | Hansen Medical Inc | Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event dur |
| 2014-12-04 | Hansen Medical Inc | The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall |
| 2009-10-19 | Hansen Medical Inc | Certain Artisan Extend Catheters may develop a leak in the flush assembly of the catheter which has the potential to cause flush fluid leakage and subsequent de |
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