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510(k) K170622

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component by Cook Incorporated — Product Code OQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2017
Date Received
March 1, 2017
Clearance Type
Special
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 Cook Incorporated

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  • K222254 — Gunther Tulip Vena Cava Filter Retrieval Set (May 16, 2023)
  • K223098 — Bakri Essential Postpartum Balloon (October 28, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)
  • K203670 — Extra Large Check-Flo Introducer (February 16, 2021)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (January 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (December 16, 2019)
  • K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult (December 12, 2019)
  • K191163 — Lumax Guiding Catheter (December 12, 2019)
  • K190084 — McLean-Ring Enteral Feeding Tube Set (October 11, 2019)

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)
  • K153591 — ebb Complete Tamponade System (January 14, 2016)
  • K150573 — ebb Complete Tamponade System (March 25, 2015)
  • K101535 — BT-CATH (January 11, 2011)
  • K091958 — BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM (April 30, 2010)