NOVA ARTERIAL EMBOLECTOMY CATHETER— 510(k) K853625

Substantially Equivalent

Nova Medical Specialties

FDA 510(k) clearance K853625 for NOVA ARTERIAL EMBOLECTOMY CATHETER, Substantially Equivalent on 1986-01-15. Applicant: Nova Medical Specialties.

Clearance details

Applicant: Nova Medical Specialties
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 1985-08-29
Decision date: 1986-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indian Mills, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.