Home / 510(k) Clearances / K073225

510(k) K073225

SENSEI CATHETER CONTROL SYSTEM by Hansen Medical, Inc. — Product Code DXX

Clearance Details

Decision
SESU ()
Decision Date
June 30, 2008
Date Received
November 15, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Catheter Control, Steerable
Device Class
Class II
Regulation Number
870.1290
Review Panel
CV
Submission Type

Other clearances by Hansen Medical, Inc.

  • K160919 — Hansen Medical Magellan Robotic Catheter 9Fr (September 20, 2016)
  • K153304 — Hansen Medical Magellan Robotic Catheter eKit (February 1, 2016)
  • K151463 — Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components (August 18, 2015)
  • K151730 — Magellan Robotic System (July 23, 2015)
  • K143227 — Magellan Robotic System, Magellan Robotic Catheter 10Fr (July 1, 2015)
  • K141614 — MAGELLAN ROBOTIC SYSTEM (August 7, 2014)
  • K133552 — MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR (February 7, 2014)
  • K132369 — MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR (September 27, 2013)
  • K122275 — ARTISAN EXTEND CONTROL CATHETER (August 29, 2012)
  • K111004 — HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER (May 29, 2012)

Other clearances for product code DXX

  • K251792 — Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (November 6, 2025)
  • K243789 — LIBERTY Endovascular Robotic System (LIBERTYOS) (September 4, 2025)
  • K221464 — CorPath GRX System (July 27, 2022)
  • K202275 — CorPath GRX System (December 11, 2020)
  • K180517 — CorPath GRX System (March 29, 2018)
  • K173806 — CorPath GRX System (March 1, 2018)
  • K173288 — CorPath GRX System (February 15, 2018)
  • K160121 — CorPath GRX System (October 27, 2016)
  • K152999 — CorPath 200 System (March 18, 2016)
  • K150892 — CorPath 200 System (October 2, 2015)