MARINR SERIES EP DIAGNOSTIC CATHETERS— 510(k) K931794

Substantially Equivalent

Medtronic Cardiorhythm

FDA 510(k) clearance K931794 for MARINR SERIES EP DIAGNOSTIC CATHETERS, Substantially Equivalent on 1994-06-06. Applicant: Medtronic Cardiorhythm.

Clearance details

Applicant: Medtronic Cardiorhythm
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1993-04-12
Decision date: 1994-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, 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.