Indy OTW Vascular Retriever— 510(k) K160593

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K160593 for Indy OTW Vascular Retriever, Substantially Equivalent on 2016-09-02. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code MMX
Advisory panel: Cardiovascular
Date received: 2016-03-01
Decision date: 2016-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, 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.