BT-CATH— 510(k) K101535

Substantially Equivalent

Utah Medical Products, Inc.

FDA 510(k) clearance K101535 for BT-CATH, Substantially Equivalent on 2011-01-11. Applicant: Utah Medical Products, Inc..

Clearance details

Applicant: Utah Medical Products, Inc.
Product code: Code OQY
Advisory panel: Obstetrics/Gynecology
Date received: 2010-06-03
Decision date: 2011-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midvale, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OQY

product code OQY

Death: 8
Injury: 616
Malfunction: 500
Total: 1,124

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.