510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K984150Substantially Equivalent

Procath Electrophysiology Catheter, Ep Medsystems Electrophysiology Catheter

Abbott Medical, West Berlin NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K984150 is the FDA 510(k) clearance record for PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER, a class II device, cleared for Ep Medsystems on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K984150.

Clearance record

Decision date
Received
(95 days to decision)
Product code
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Ep Medsystems Cooper Run Executive Park, West Berlin NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DRF

Trailing 12 months
2 clearances under product code DRF in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRF, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260