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510(k) K152129

FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution by Baxter Healthcare Corporation — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2015
Date Received
July 31, 2015
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

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  • K214016 — 15L Cycler Drainage Bag (March 18, 2022)
  • 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)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)
  • K124024 — APD LUER-LOCK ADAPTER (September 19, 2013)