HEARTRAIL III GUIDING CATHETER— 510(k) K113335

Substantially Equivalent

Terumo Corporation

FDA 510(k) clearance K113335 for HEARTRAIL III GUIDING CATHETER, Substantially Equivalent on 2012-07-16. Applicant: Terumo Corporation.

Clearance details

Applicant: Terumo Corporation
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2011-11-14
Decision date: 2012-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Shibuya-Ku, Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.