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510(k) K082075

HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER by Hansen Medical, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2008
Date Received
July 23, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
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)

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  • K241720 — VersaCross Connect™ Transseptal Dilator (July 12, 2024)
  • K233647 — VersaCross Connect™ Transseptal Dilator (December 14, 2023)
  • K232609 — Micro Ace™ Advanced Micro Access System (September 27, 2023)
  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
  • K211679 — Xtractor device (February 17, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)