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510(k) K012926

MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 by Endocardial Solutions, Inc. — Product Code MTD

Clearance Details

Decision
SESU ()
Decision Date
September 28, 2001
Date Received
August 31, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intracardiac Mapping, High-Density Array
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Endocardial Solutions, Inc.

  • K042493 — ENSITE SYSTEM, MODEL EE3000 (October 15, 2004)
  • K033211 — ENSITE SYSTEM (October 30, 2003)
  • K030129 — MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (April 22, 2003)
  • K001437 — ENSITE 3000 SYSTEM, MODEL EE3000 (June 7, 2000)
  • K993376 — ENSTYLET MODELS EC0010, EC0020 (January 5, 2000)
  • K992479 — ENSITE 3000 SYSTEM (December 2, 1999)
  • K983456 — ENSITE 3000 SYSTEM (April 21, 1999)

Other clearances for product code MTD

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  • K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009) (August 7, 2024)
  • K241372 — Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (July 9, 2024)
  • K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webs (July 10, 2023)
  • K223666 — Ablacath™ Mapping Catheter (March 17, 2023)
  • K230253 — OPTRELL™ Mapping Catheter with TRUEref™ Technology (March 2, 2023)
  • K210766 — AcQMap 3D Imaging and Mapping Catheter, Model 900009 (June 21, 2022)
  • K211438 — OPTRELL Mapping Catheter with TRUEref Technology (March 18, 2022)
  • K201806 — Reprocessed PentaRay Nav eco High-Density Mapping Catheter (June 23, 2021)
  • K201341 — AcQMap 3D Imaging and Mapping Catheter (September 15, 2020)