Artisan Extend Control Catheter
FDA 510(k) K122275 · Hansen Medical
510(k) numberK122275
Submission
- Device name
- Artisan Extend Control Catheter
- Applicant
- Hansen Medical
Mountain View, CA, US - Received
- July 30, 2012
- Decision date
- August 29, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRA – Catheter, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1280
- Specialty
- Cardiovascular
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| 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 |
| K132369 | Magellan Robotic System, Magellan Robotic Catheter 9FRDXX · Special | 09/27/2013SE |
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Questions and answers
When was Artisan Extend Control Catheter cleared by the FDA?
Artisan Extend Control Catheter (K122275) received a 510(k) decision of Substantially Equivalent on August 29, 2012, 30 days after the submission was received.
What is the product code of K122275?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.