Map-it Diagnostic Mapping Catheters— 510(k) K160390

Substantially Equivalent

Access Point Technologies Ep, Inc.

FDA 510(k) clearance K160390 for Map-it Diagnostic Mapping Catheters, Substantially Equivalent on 2016-04-11. Applicant: Access Point Technologies Ep, Inc..

Clearance details

Applicant: Access Point Technologies Ep, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2016-02-11
Decision date: 2016-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rogers, MN, 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.