NES Reprocessed Visions PV .014P RX Digital IVUS Catheter— 510(k) K200195

Substantially Equivalent

Northeast Scientific, Inc.

FDA 510(k) clearance K200195 for NES Reprocessed Visions PV .014P RX Digital IVUS Catheter, Substantially Equivalent on 2020-06-22. Applicant: Northeast Scientific, Inc..

Clearance details

Applicant: Northeast Scientific, Inc.
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2020-01-27
Decision date: 2020-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterbury, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

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.