ONO Retrieval Device— 510(k) K212988

Substantially Equivalent

Onocor Vascular, LLC

FDA 510(k) clearance K212988 for ONO Retrieval Device, Substantially Equivalent on 2022-05-23. Applicant: Onocor Vascular, LLC.

Clearance details

Applicant: Onocor Vascular, LLC
Product code: Code MMX
Advisory panel: Cardiovascular
Date received: 2021-09-20
Decision date: 2022-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MMX

product code MMX

Death: 3
Total: 3

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.