Magellan Robotic System, Magellan Robotic Catheter 9FR
FDA 510(k) K132369 · Hansen Medical, Inc.
510(k) numberK132369
Submission
- Device name
- Magellan Robotic System, Magellan Robotic Catheter 9FR
- Applicant
- Hansen Medical, Inc.
Mountain View, CA, US - Received
- July 30, 2013
- Decision date
- September 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXX – System, Catheter Control, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1290
- Specialty
- Cardiovascular
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| K173288 | CorPath GRX SystemDXX · Traditional | Corindus, Inc. | 02/15/2018SE |
| K160121 | CorPath GRX SystemDXX · Traditional | Corindus, Inc. | 10/27/2016SE |
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More from Corindus, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160919 | Hansen Medical Magellan Robotic Catheter 9FrDRA · Traditional | 09/20/2016SE |
| K153304 | Hansen Medical Magellan Robotic Catheter eKitDRA · Traditional | 02/01/2016SE |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsDRA · Special | 08/18/2015SE |
| K151730 | Magellan Robotic SystemDXX · Special | 07/23/2015SE |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10FrDXX · Traditional | 07/01/2015SE |
| K141614 | Magellan Robotic SystemDXX · Traditional | 08/07/2014SE |
| K133552 | Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR…DRA · Special | 02/07/2014SE |
| K122275 | Artisan Extend Control CatheterDRA · Special | 08/29/2012SE |
| K111004 | Hansen Medical Vascular Catheter Control System and CatheterDXX · Traditional | 05/29/2012SE |
| K102168 | Sensei X Robotic Catheter SystemDXX · Special | 10/22/2010SE |
Questions and answers
When was Magellan Robotic System, Magellan Robotic Catheter 9FR cleared by the FDA?
Magellan Robotic System, Magellan Robotic Catheter 9FR (K132369) received a 510(k) decision of Substantially Equivalent on September 27, 2013, 59 days after the submission was received.
What is the product code of K132369?
The FDA product code is DXX – System, Catheter Control, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1290.