PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25— 510(k) K061678

Substantially Equivalent

Prorhythm

FDA 510(k) clearance K061678 for PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25, Substantially Equivalent on 2007-01-12. Applicant: Prorhythm.

Clearance details

Applicant: Prorhythm
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2006-06-15
Decision date: 2007-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronkonkoma, NY, US

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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.