Terumo Circuit Tubing— 510(k) K150536
Substantially EquivalentTerumo Cardiovascular Systems Corporation
FDA 510(k) clearance K150536 for Terumo Circuit Tubing, Substantially Equivalent on 2015-05-05. Applicant: Terumo Cardiovascular Systems Corporation.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corporation
- Product code
- Code DWF
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ashland, MA, US
Adverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
Source: openFDA MAUDE database, through . 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.