CATH BELT PD CATHETER AND TRANSFER SET HOLDER— 510(k) K930175

Substantially Equivalent

Tabex Industries, Inc.

FDA 510(k) clearance K930175 for CATH BELT PD CATHETER AND TRANSFER SET HOLDER, Substantially Equivalent on 1994-06-23. Applicant: Tabex Industries, Inc..

Clearance details

Applicant: Tabex Industries, Inc.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 1993-01-13
Decision date: 1994-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.