NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH— 510(k) K860526

Substantially Equivalent

Nova Medical Specialties

FDA 510(k) clearance K860526 for NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH, Substantially Equivalent on 1986-05-02. Applicant: Nova Medical Specialties.

Clearance details

Applicant: Nova Medical Specialties
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 1986-02-11
Decision date: 1986-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indian Mills, NJ, US

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Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.