TITANIUM GREENFIELD VENA CAVA FILTER CARRIER— 510(k) K874096

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K874096 for TITANIUM GREENFIELD VENA CAVA FILTER CARRIER, Substantially Equivalent on 1988-11-04. Applicant: Medi-Tech, Inc..

Clearance details

Applicant
Medi-Tech, Inc.
Product code
Code DTK
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Watertown, MA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DTK

product code DTK
Death
208
Injury
11,286
Malfunction
3,002
Total
14,496

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.