TERUMO LAUER LOCK ADAPTER— 510(k) K093992

Substantially Equivalent

Terumo Cardiovascular Systems Corporation

FDA 510(k) clearance K093992 for TERUMO LAUER LOCK ADAPTER, Substantially Equivalent on 2010-05-19. Applicant: Terumo Cardiovascular Systems Corporation.

Clearance details

Applicant
Terumo Cardiovascular Systems Corporation
Product code
Code DTL
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Elkton, MD, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DTL

product code DTL
Malfunction
770
Total
770

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.