BT-CATH— 510(k) K101535

Name: FDA 510(k) clearance K101535
Creator: U.S. Food and Drug Administration
Published: 2011-01-11

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.. Device class: 2.

Clearance details

Applicant: Utah Medical Products, Inc.
Product code: Code OQY
Device class: Class 2
Regulation: 21 CFR 884.4530
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 ↗

Recent devices under product code OQY

view all

K253642 — Jada System (Jada-2002)2026-05-15
K230849 — ELLAVI UBT2023-11-13
K223098 — Bakri Essential Postpartum Balloon2022-10-28
K212757 — Jada System2021-09-30
K201199 — Jada System2020-08-28

More clearances from Utah Medical Products, Inc.

view all

K143424 — UTAH CVX-RIPE2015-08-28
K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)2013-01-23
K063611 — SALINE/ CONTRAST MEDIA INFUSION CATHETER2007-05-23
K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER2000-09-25
K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX2000-05-23

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.