Bt-Cath
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- BT-CATH EUDAMEDFDA UDI
- Generic Name
- Intrauterine haemostatic balloon catheter FDA UDI
- Device Name
- BT-Cath EUDAMEDBalloon Tamponade Catheter for Postpartum Uterine Hemorrhage with EasyFill Inflation System FDA UDI
- Model / Reference
- BTC-ESY EUDAMEDEasyFill FDA UDI
- Description
- Balloon Tamponade Catheter for Postpartum Uterine Hemorrhage with EasyFill Inflation System FDA UDI
Identifiers
- Catalog Number
- BTC-ESY FDA UDI
- Primary DI / UDI-DI
- H671BTCESY0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++H671CE033IIACZ EUDAMED
- 510(k) Number
- FDA Product Code
- OQY FDA 510(k)FDA UDI
- EMDN Code
- U100199 OBSTETRICAL CATHETERS - OTHER EUDAMED
- GMDN Term
- Intrauterine haemostatic balloon catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 884.4530 FDA 510(k)
- Regulation Number
- 884.4530 FDA 510(k)FDA UDI
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The BT-Cath Balloon Tamponade Catheter is an Intrauterine Tamponade Balloon, classified as a Class II medical device under FDA regulations (884.4530). Designed for obstetrics and gynecology, it applies direct pressure to the uterine cavity to temporarily control or reduce severe postpartum hemorrhage when standard interventions—such as uterine massage and oxytocin administration—have failed.
This device is supplied as a single-use, non-sterile catheter intended for sterile preparation prior to use. It is intended for use in obstetric settings and must be handled under aseptic conditions. The BT-Cath is authorized under FDA 510(k) clearance (K101535) and meets EU MDR requirements. Multiple registration numbers (e.g., 1216677, 1721676) reflect its distribution across various global markets, with no MRI safety restrictions specified.
Frequently asked questions
What is the BT-Cath Balloon Tamponade Catheter used for in clinical practice?
The BT-Cath is designed to control or reduce severe postpartum hemorrhage when standard interventions like uterine massage and oxytocin administration are ineffective. It works by applying direct pressure to the uterine cavity, providing temporary tamponade in obstetric settings where bleeding persists despite initial measures.
Is the BT-Cath Balloon Tamponade Catheter sterile when received, and how should it be prepared for use?
The BT-Cath is supplied as a single-use, non-sterile catheter, meaning it must be sterilized prior to use. Since it is intended for sterile application in obstetrics, it should be handled under aseptic conditions, following standard sterilization protocols before deployment in the uterine cavity.
How is the BT-Cath Balloon Tamponade Catheter regulated, and what markets does it serve?
The BT-Cath is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance (K101535). It also complies with the EU MDR and is distributed globally, evidenced by multiple registration numbers (e.g., 1216677, 1721676) across various markets. No MRI safety restrictions are specified.
Can the BT-Cath Balloon Tamponade Catheter be reused, or is it intended for one-time use?
The BT-Cath is explicitly labeled as a single-use device. Due to its sterile application in obstetrics, reuse is not recommended or supported by the manufacturer, as it could compromise patient safety and device efficacy.
What regulatory pathway was followed for the BT-Cath’s approval, and which advisory committee reviewed it?
The BT-Cath underwent a traditional 510(k) review under the FDA’s Obstetrics/Gynecology advisory committee (OB). The device was determined to be substantially equivalent to a predicate, with clearance granted on January 11, 2011, following submission on June 3, 2010.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BT-Cath Balloon Tamponade Catheters for PPH treatment - Utah Med, PDF BT-Cath® - Utah Medical Products, PDF BT-Cath® - Utah Medical Products, PDF SECTION 9: 510(k) SUMMARY 5 1 0(k) Owner: Utah Medical Products, Inc ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101535 | Class II | Active |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (3)
- FDA 510(k) K101535 24 fields · synced Oct 6, 2026
- FDA UDI c2e92c6b-ab57-412c-bdff-6a6ca9f2880c 36 fields · synced May 30, 2026
- EUDAMED 83311f97-b2ef-4453-a4b3-9f49b3b86127 61 fields · synced Jul 10, 2026