CS MEDICAL ADULT TTCF CATHETER— 510(k) K050379

Substantially Equivalent

Cs Medical, Inc.

FDA 510(k) clearance K050379 for CS MEDICAL ADULT TTCF CATHETER, Substantially Equivalent on 2005-07-12. Applicant: Cs Medical, Inc..

Clearance details

Applicant: Cs Medical, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 2005-02-15
Decision date: 2005-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.