FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm— 510(k) K161967

Substantially Equivalent

Callisyn Biomedical, Inc.

FDA 510(k) clearance K161967 for FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm, Substantially Equivalent on 2017-01-27. Applicant: Callisyn Biomedical, Inc..

Clearance details

Applicant: Callisyn Biomedical, Inc.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 2016-07-18
Decision date: 2017-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Andover, MA, US

Download summary PDF View on FDA.gov ↗

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.