R2P SlenGuide— 510(k) K161546

Substantially Equivalent

Ashitaka Factory of Terumo Corporation

FDA 510(k) clearance K161546 for R2P SlenGuide, Substantially Equivalent on 2016-10-14. Applicant: Ashitaka Factory of Terumo Corporation.

Clearance details

Applicant: Ashitaka Factory of Terumo Corporation
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2016-06-03
Decision date: 2016-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fujinomiya Shizuoka, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.