MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR— 510(k) K132369
Substantially EquivalentHansen Medical, Inc.
FDA 510(k) clearance K132369 for MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR, Substantially Equivalent on 2013-09-27. 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
- Special
- Location
- Mountain View, CA, US
Recent devices under product code DXX
view allMore clearances from Hansen Medical, Inc.
view allRecalls naming K132369
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 K132369.
Data sourced from openFDA. This site is unofficial and independent of the FDA.