Home / 510(k) Clearances / K033963

510(k) K033963

EP DEFLECTABLE CATHETERS by Ep Medsystems, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2004
Date Received
December 22, 2003
Clearance Type
Special
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 Medsystems, Inc.

  • K092913 — EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 (October 16, 2009)
  • K073709 — MODIFICATION TO VIEWMATE SYSTEM (March 11, 2008)
  • K071028 — VIEWMATE SYSTEM (May 1, 2007)
  • K070706 — EP-WORKMATE (April 11, 2007)
  • K063277 — MAPMATE (November 30, 2006)
  • K063113 — EP-WORKMATE (October 27, 2006)
  • K041442 — EP-4 CLINICAL STIMUTATOR (September 14, 2004)
  • K040207 — EP-4 CLINICAL STIMULATOR (February 27, 2004)
  • K031066 — VIEWMATE ULTRASOUND IMAGING SYSTEM (October 17, 2003)
  • K032225 — EP-WORKMATE WITH RPM SYSTEM (August 20, 2003)

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)