PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER— 510(k) K984150

Name: FDA 510(k) clearance K984150
Creator: U.S. Food and Drug Administration
Published: 1999-02-22

Substantially Equivalent

Ep Medsystems

FDA 510(k) clearance K984150 for PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER, Substantially Equivalent on 1999-02-22. Applicant: Ep Medsystems. Device class: 2.

Clearance details

Applicant: Ep Medsystems
Product code: Code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 1998-11-19
Decision date: 1999-02-22
Decision: Substantially Equivalent
Clearance type: Special
Location: West Berlin, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRF

view all

K252794 — Vision-MR Diagnostic Catheter2026-01-08
K250590 — MAGiC Sweep EP Mapping Catheter2025-07-23
K250310 — VIKING Fixed Curve Diagnostic Catheter2025-06-27
K240366 — EPXT Unidirectional Steerable Diagnostic Catheter +2 more2024-11-01
K233900 — Nordica PV Cryo Mapping Catheter2024-09-06

More clearances from Ep Medsystems

view all

K092913 — EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-042009-10-16
K073709 — MODIFICATION TO VIEWMATE SYSTEM2008-03-11
K071028 — VIEWMATE SYSTEM2007-05-01
K070706 — EP-WORKMATE2007-04-11
K063113 — EP-WORKMATE2006-10-27

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.