CAPIOX HARDSHELL VENOUS RESERVOIR— 510(k) K894664

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K894664 for CAPIOX HARDSHELL VENOUS RESERVOIR, Substantially Equivalent on 1990-04-20. Applicant: Terumo Medical Corp..

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1989-07-24
Decision date: 1990-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTN

product code DTN

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.