# K061678: Prorhythm Promap Coaxial Mapping Catheter, Models Pri-Map-15, Pri-Map-20, Pri-Map-25

- Pathway: 510(k) (Traditional)
- Applicant: Prorhythm
- Decided: Jan 12, 2007 after 211 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Biosense Webster Lasso Deflectable Circular Mapping Catheter: named in the summary without a submission number
- (no number) Cardimna, Inc Pathfinder Catheter: named in the summary without a submission number

## Indications for use
The ProRhythrmTM ProMap is to be used for the evaluation of cardiac arrhythmias from endocardial and intravascular sites. The ProMap Coaxial Mapping Catheter is typically used in Electrophysiology clinical procedures.

Source page: https://510kreport.com/device/K061678
Methodology: https://510kreport.com/methodology