Home / 510(k) Clearances / K940167

510(k) K940167

DIAGNOSTIC I CATHETER by Ep Technologies, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1994
Date Received
January 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Ep Technologies, Inc.

  • K043257 — REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM (February 3, 2005)
  • K013349 — ASTRONOMER PLUS SYSTEM (April 9, 2002)
  • K003452 — POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D (December 7, 2000)
  • K940168 — DIAGNOSTIC II CATHETER (July 27, 1994)
  • K924109 — STEEROCATH II (December 16, 1993)
  • K924108 — TRACFINDER II (December 16, 1993)
  • K913375 — TORQUE TUBE STEEROCATH(TM) (October 25, 1991)
  • K903880 — FRANZ(TM) STEERABLE COMBINATION CATHETER (October 12, 1990)
  • K900765 — STEEROCATH(TM) (May 7, 1990)
  • K900452 — QUATTRO CATHETER (March 14, 1990)

Other clearances for product code DRF

  • K252794 — Vision-MR™ Diagnostic Catheter (January 8, 2026)
  • K250590 — MAGiC Sweep™ EP Mapping Catheter (July 23, 2025)
  • K250310 — VIKING™ Fixed Curve Diagnostic Catheter (June 27, 2025)
  • K240366 — EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional (November 1, 2024)
  • K233900 — Nordica PV Cryo Mapping Catheter (September 6, 2024)
  • K233397 — Cosine-10TM Diagnostic Catheter (December 2, 2023)
  • K233207 — Polaris X™ Unidirectional Steerable Diagnostic Catheter (October 27, 2023)
  • K232651 — BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter (September 29, 2023)
  • K230503 — Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (April 25, 2023)
  • K210313 — EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter (December 30, 2022)