BT-CATH
FDA 510(k) clearance K101535 · decided 2011-01-11
Clearance details
- K-number
- K101535
- Device name
- BT-CATH
- Applicant
- Utah Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-03
- Decision date
- 2011-01-11
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- OQY
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Midvale, UT, US
- Third-party review
- No
- Expedited review
- No
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| Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (K170622) | Cook Incorporated | 2017-03-31 |
| ebb Complete Tamponade System (K153591) | Clinical Innovations, LLC | 2016-01-14 |
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| BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM (K091958) | Glenveigh Surgical, LLC | 2010-04-30 |
Recalls involving this device
No recalls on record reference this clearance.