510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K061678Substantially Equivalent

Prorhythm Promap Coaxial Mapping Catheter, Models Pri-Map-15, Pri-Map-20, Pri-Map-25

Prorhythm, Ronkonkoma NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061678 is the FDA 510(k) clearance record for PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25, a class II device, cleared for Prorhythm on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list one 510(k) clearance for Prorhythm. As of , FDA records show no recalls naming K061678.

Clearance record

Decision date
Received
(211 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
Prorhythm 105 Comac St., Ronkonkoma NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRF

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