510(k) K954457— MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER

Substantially Equivalent

Medi-Tech, Inc.

Clearance details

Applicant: Medi-Tech, Inc.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 1995-09-25
Decision date: 1996-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.