CARDIOCATH CATHETERIZATION LAB SYSTEM— 510(k) K960321

Substantially Equivalent

Prucka Engineering, Inc.

FDA 510(k) clearance K960321 for CARDIOCATH CATHETERIZATION LAB SYSTEM, Substantially Equivalent on 1996-08-21. Applicant: Prucka Engineering, Inc..

Clearance details

Applicant: Prucka Engineering, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1996-01-22
Decision date: 1996-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.