Bt-Cath

FDA 510(k) K101535 · Utah Medical Products, Inc.

Substantially Equivalent

510(k) numberK101535

Submission

Device name
Bt-Cath
Applicant
Utah Medical Products, Inc.
Midvale, UT, US
Received
June 3, 2010
Decision date
January 11, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OQY – Intrauterine Tamponade Balloon
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

provides temporary control or reduction of postpartum uterine bleeding

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Questions and answers

When was Bt-Cath cleared by the FDA?

Bt-Cath (K101535) received a 510(k) decision of Substantially Equivalent on January 11, 2011, 222 days after the submission was received.

What is the product code of K101535?

The FDA product code is OQY – Intrauterine Tamponade Balloon, a Class II (moderate risk) device regulated under 21 CFR 884.4530.