IntellaMap Orion High Resolution Mapping Catheter— 510(k) K143481

Substantially Equivalent

Rhythmia Medical, Inc.

FDA 510(k) clearance K143481 for IntellaMap Orion High Resolution Mapping Catheter, Substantially Equivalent on 2015-01-08. Applicant: Rhythmia Medical, Inc..

Clearance details

Applicant: Rhythmia Medical, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2014-12-08
Decision date: 2015-01-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Burlington, MA, 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.