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510(k) K214016

15L Cycler Drainage Bag by Baxter Healthcare Corporation — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2022
Date Received
December 22, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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Other clearances for product code KDJ

  • K250404 — stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter (April 3, 2025)
  • K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap E (March 12, 2024)
  • K192705 — MiniCap Extended Life PD Transfer Sets (October 25, 2019)
  • K173593 — stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter ext (May 21, 2018)
  • K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (February 14, 2018)
  • K173363 — Cycler Drain Bag Set (January 24, 2018)
  • K151620 — Firefly Peritoneal Dialysis Connector Disinfection System (January 20, 2016)
  • K152129 — FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iod (October 29, 2015)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)
  • K124024 — APD LUER-LOCK ADAPTER (September 19, 2013)