HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER— 510(k) K111004
Substantially EquivalentHansen Medical, Inc.
FDA 510(k) clearance K111004 for HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER, Substantially Equivalent on 2012-05-29. Applicant: Hansen Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Hansen Medical, Inc.
- Product code
- Code DXX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1290
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Recent devices under product code DXX
view allMore clearances from Hansen Medical, Inc.
view allRecalls naming K111004
K-number listed on FDA's recall record- Z-1564-2016 — Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
- Z-1449-2015 — Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111004.
Data sourced from openFDA. This site is unofficial and independent of the FDA.