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510(k) K101535

BT-CATH by Utah Medical Products, Inc. — Product Code OQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2011
Date Received
June 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intrauterine Tamponade Balloon
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

provides temporary control or reduction of postpartum uterine bleeding

Other clearances by Utah Medical Products, Inc.

  • K143424 — UTAH CVX-RIPE (August 28, 2015)
  • K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) (January 23, 2013)
  • K063611 — SALINE/ CONTRAST MEDIA INFUSION CATHETER (May 23, 2007)
  • K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER (September 25, 2000)
  • K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX (May 23, 2000)
  • K965245 — TBD (July 3, 1997)
  • K970077 — LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) (May 23, 1997)
  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
  • K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER (February 10, 1997)
  • K961424 — INTRAN 500 (July 10, 1996)

Other clearances for product code OQY

  • K230849 — ELLAVI UBT (November 13, 2023)
  • K223098 — Bakri Essential Postpartum Balloon (October 28, 2022)
  • K212757 — Jada System (September 30, 2021)
  • K201199 — Jada System (August 28, 2020)
  • K191264 — Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) (October 30, 2019)
  • K170622 — Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Compo (March 31, 2017)
  • K153591 — ebb Complete Tamponade System (January 14, 2016)
  • K150573 — ebb Complete Tamponade System (March 25, 2015)
  • K091958 — BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM (April 30, 2010)