PE INTERCARDIAC MAPPING SYSTEM (ICMS)— 510(k) K895916

Substantially Equivalent

Prucka Engineering, Inc.

FDA 510(k) clearance K895916 for PE INTERCARDIAC MAPPING SYSTEM (ICMS), Substantially Equivalent on 1989-12-13. Applicant: Prucka Engineering, Inc..

Clearance details

Applicant: Prucka Engineering, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1989-10-10
Decision date: 1989-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellaire, TX, 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.