FDA.reportPublic FDA data

Sensei®

Primary DI
00815671020260
Brand
Sensei®
Company
HANSEN MEDICAL, INC.
Model
SRS200
Catalog number
SRS200
Device description
Sensei X2 Robotic System 120V
Published
2016-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXXSystem, Catheter Control, Steerable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXXSystem, Catheter Control, SteerableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815671020260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815671020260008156710202608156710202600815671020260

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system workstationA mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-650-404-5844xx@xx.xx
1-866-426-0804xx@xx.xx

Regulatory Flags#

DUNS number
128941304
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815671020079Magellan™MRCCADMRCCAD2016-09-23
00815671020017Magellan™MC9F50MC9F502016-09-23
00815671020024Magellan™MC9F65MC9F652016-09-23
00815671020031Magellan™MC9F80MC9F802016-09-23
00815671020116Magellan™MC6F60MC6F602016-09-23
00815671020123Magellan™MC6F95MC6F952016-09-23
00815671020154Magellan™MC10F50MC10F502016-09-23
00815671020161Magellan™MC10F65MC10F652016-09-23
00815671020178Magellan™MC10F80MC10F802016-09-23
00815671020185Magellan™MCE60MCE602016-09-23
00815671020192Magellan™MCE95MCE952016-09-23
00815671020222Magellan™ML60ML602016-09-23
00815671020239Magellan™ML95ML952016-09-23
00815671020048Magellan™MACC50MACC502016-09-23
00815671020055Magellan™MACC65MACC652016-09-23
00815671020062Magellan™MACC80MACC802016-09-23
00815671020130Magellan™MA6F60MA6F602016-09-23
00815671020147Magellan™MA6F95MA6F952016-09-23
00815671020208Magellan™MAE60MAE602016-09-23
00815671020215Magellan™MAE95MAE952016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M58800101400010GenesisXStereotaxis, Inc.DXX2026-01-09
07290019564003LIBERTY Endovascular Robotic SystemMICROBOT MEDICAL LTDDXX2025-11-18
07290019564058LIBERTY Endovascular Robotic System - robotMICROBOT MEDICAL LTDDXX2025-11-18
07290019564102LIBERTY Endovascular Robotic System - armMICROBOT MEDICAL LTDDXX2025-11-18
00816280023192CorPath GRX Cassette DuoCorindus, Inc.DXX2022-08-08
00816280023185CorPath GRX Cassette DuoCORINDUS, INC.DXX2022-08-08
00816280023123CorPath GRX Extended Reach ArmCorindus, Inc.DXX2018-04-05
00816280023017CorPath GRX Control ConsoleCorindus, Inc.DXX2017-01-20
00816280023024CorPath GRX Extended Reach ArmCorindus, Inc.DXX2017-01-20
00816280023031CorPath GRX Robotic DriveCorindus, Inc.DXX2017-01-20
00816280023055CorPath GRX CassetteCorindus, Inc.DXX2017-01-20
00816280023079CorPath GRX Drive GearCorindus, Inc.DXX2017-01-20
00816280023093CorPath GRX Drape, Robotic Drive and ArmCorindus, Inc.DXX2017-01-20
00816280023116CorPath GRX Drape, Control ConsoleCorindus, Inc.DXX2017-01-20
00815671020246Sensei®HANSEN MEDICAL, INC.DXX2016-09-30
00815671020284Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00815671020314Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00815671020321Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00816280022010CorPath 200 Control ConsoleCorindus, Inc.DXX2016-09-24
00816280022027CorPath 200 Articulated ArmCorindus, Inc.DXX2016-09-24
00816280022034CorPath 200 Robotic DriveCorindus, Inc.DXX2016-09-24
00816280022041CorPath 200 CassetteCorindus, Inc.DXX2016-09-24
00816280022072CorPath 200 POGO Pin CapsCorindus, Inc.DXX2016-09-24
00816280022096CorPath 200 Control Console DrapeCorindus, Inc.DXX2016-09-24
00816280022119CorPath 200 Joystick CoversCorindus, Inc.DXX2016-09-24
00816280022133CorPath 200 Robotic Drive DrapeCorindus, Inc.DXX2016-09-24
10815671020007Artisan®HANSEN MEDICAL, INC.DXX2016-09-23
10815671020083Magellan™HANSEN MEDICAL, INC.DXX2016-09-23
00815671020048Magellan™HANSEN MEDICAL, INC.DXX2016-09-23
00815671020055Magellan™HANSEN MEDICAL, INC.DXX2016-09-23