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Sign in to claim this brandHansen Medical, Inc.
US
Last updated May 27, 2026
What Hansen Medical, Inc. makes
Hansen Medical, Inc. manufactures single-use vascular guide-catheters, including the Magellan™ series, designed for interventional procedures. The company also produces sterile general-purpose catheter connectors and sterile, single-use instrument drapes, alongside reusable instrument trays. Cardiac ventriculography catheters are part of its portfolio, catering to diagnostic imaging needs in cardiac care.
The company’s products are classified as Class II medical devices under FDA regulations, with most authorised through the 510(k) and UDI pathways. These devices are listed in the FDA’s regulatory databases, ensuring compliance with US medical device standards. Hansen Medical, Inc. is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Hansen Medical, Inc. manufacture?
Hansen Medical, Inc. specialises in vascular and cardiac medical devices, primarily producing single-use vascular guide-catheters like the Magellan™ series for interventional procedures. Their portfolio also includes sterile general-purpose catheter connectors, single-use sterile instrument drapes, and reusable instrument trays. Additionally, they manufacture cardiac ventriculography catheters, which are used in diagnostic imaging for cardiac care.
Where is Hansen Medical, Inc. based, and how does that affect its regulatory compliance?
Hansen Medical, Inc. is headquartered in the United States, meaning its devices are subject to FDA regulations. Since the company’s products fall under Class II classification, they must comply with FDA requirements for medical devices, including pathways like the 510(k) premarket notification process and Unique Device Identification (UDI) rules. This ensures their devices meet US safety and performance standards.
Which regulatory registries or databases list Hansen Medical, Inc.’s devices?
Hansen Medical, Inc.’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the UDI system. These registries confirm that the devices have undergone evaluation for compliance with US medical device regulations, ensuring transparency and traceability for healthcare providers and regulators.
How are Hansen Medical, Inc.’s devices classified under FDA regulations?
Hansen Medical, Inc.’s devices are classified as Class II medical devices under FDA regulations. This classification applies to products that generally pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure their safety and effectiveness. Most of their devices, including vascular guide-catheters and cardiac catheters, follow this classification.
Why do some of Hansen Medical, Inc.’s devices require a 510(k) or UDI listing?
The 510(k) pathway is used for Class II devices to demonstrate that a new product is substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance standards. The UDI system assigns a unique identifier to each device to improve tracking, reduce medical errors, and enhance post-market surveillance. Since Hansen Medical’s devices are Class II, these pathways ensure they comply with regulatory requirements before entering the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 1-866-426-0804
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 128941304
Catalogue (45)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Magellan™ | MA6F60 | FDA UDI | Class II | Active |
| Magellan™ | MC6F95 | FDA UDI | Class II | Active |
| Artisan Extend® | 12412 | FDA UDI | Class II | Active |
| Magellan™ | MTS100 | FDA UDI | Class II | Unknown |
| Magellan™ | MACC50 | FDA UDI | Class II | Active |
| Magellan™ | MC6F60 | FDA UDI | Class II | Active |
| Magellan™ | 11132 | FDA UDI | Class II | Unknown |
| Magellan™ | MC10F50 | FDA UDI | Class II | Active |
| Sensei® | 08257 | FDA UDI | Class II | Unknown |
| Magellan™ | MA6F95 | FDA UDI | Class II | Active |
| Magellan™ | MCE60 | FDA UDI | Class II | Active |
| Magellan™ | MD6PK | FDA UDI | Class II | Active |
| Magellan™ | ML95 | FDA UDI | Class II | Active |
| Magellan™ | MCE95 | FDA UDI | Class II | Active |
| Magellan™ | MC10F80 | FDA UDI | Class II | Active |
| Magellan™ | MAE60 | FDA UDI | Class II | Active |
| Magellan™ | MACC80 | FDA UDI | Class II | Active |
| Magellan™ | MC10F65 | FDA UDI | Class II | Active |
| Magellan™ | MAR100 | FDA UDI | Class II | Unknown |
| Magellan™ | MRCCAD | FDA UDI | Class II | Active |
| Magellan™ | MC9F80 | FDA UDI | Class II | Active |
| Artisan® | 06196 | FDA UDI | Class II | Active |
| Magellan™ | MC9F65 | FDA UDI | Class II | Active |
| Sensei® | SRS200 | FDA UDI | Class II | Unknown |
| Magellan™ | ML60 | FDA UDI | Class II | Active |
| Magellan™ | MAE95 | FDA UDI | Class II | Active |
| Magellan™ | MACC65 | FDA UDI | Class II | Active |
| Magellan™ | MC9F50 | FDA UDI | Class II | Active |
| Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | K151463 | FDA 510(k) | Class II | Active |
| Magellan Robotic Catheter 6fr (guide And Leader), Magellan Robotic Catheter 6fr Accessory Kit | K133552 | FDA 510(k) | Class II | Active |
| Hansen Medical Vascular Catheter Control System And Catheter | K111004 | FDA 510(k) | Class II | Active |
| Hansen Medical Dilator For Artisan Control Catheter | K082075 | FDA 510(k) | Class II | Active |
| Hansen Medical Magellan Robotic Catheter 9Fr | K160919 | FDA 510(k) | Class II | Active |
| Magellan Robotic System, Magellan Robotic Catheter 10Fr | K143227 | FDA 510(k) | Class II | Active |
| Sensei X Robotic Catheter System | K102168 | FDA 510(k) | Class II | Active |
| Magellan Robotic System | K151730 | FDA 510(k) | Class II | Active |
| Hansen Medical Artisan S Control Catheter | K090365 | FDA 510(k) | Class II | Active |
| Magellan Robotic System | K141614 | FDA 510(k) | Class II | Active |
| Sensei Catheter Control System | K073225 | FDA 510(k) | Class II | Active |
| Hansen Medical Transseptal Needle And Dilator | K061070 | FDA 510(k) | Class II | Active |
| Sensei Robotic Catheter System, Model 02057 | K091808 | FDA 510(k) | Class II | Active |
| Artisan Extend Control Catheter | K122275 | FDA 510(k) | Class II | Active |
| Hansen Medical Catheter Control System (ccs) And Accessories, Hansen Medical Steerable Guide Catheter (sgc) And Sheath | K052480 | FDA 510(k) | Class II | Active |
| Hansen Medical Magellan Robotic Catheter eKit | K153304 | FDA 510(k) | Class II | Active |
| Magellan Robotic System, Magellan Robotic Catheter 9fr | K132369 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Hansen Medical, Inc. has five recall records initiated between May 21, 2008, and March 25, 2016, all of which are marked as terminated. The recalls involved issues such as potential leaks in catheters, unexpected retraction malfunctions in robotic systems, insufficient radiation dosing in a product batch, and loose subassemblies in robotic catheter systems that could affect device stability. Reasons cited include manufacturing deviations, design-related risks, and performance inconsistencies during testing or use.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 25, 2016 | Z-1564-2016 | — | terminated | 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. |
| Mar 18, 2015 | Z-1449-2015 | — | terminated | Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop when equipment button is released. |
| Dec 4, 2014 | Z-0896-2015 | — | terminated | 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 causing, uncontrolled catheter movement. cardiac tampenade, delayed procedure, or crush injury to the patient and/or user. |
| Oct 19, 2009 | Z-1251-2010 | — | terminated | 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 decrease in distal flush; inability to aspirate air from flush lines, and/or introduction of air into the catheter. |
| May 21, 2008 | Z-2106-2008 | — | terminated | The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequent embolism. |