FDA 510(k), K152129, FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution

FDA 510(k), K152129, FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution

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510(K) Number: K152129
Device Name: FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
Manufacturer: TIFFANY LIN
Device Classification Name: Set, Administration, For Peritoneal Dialysis, Disposable
Regulation Number: KDJ
Classification Product Code: KXA
Date Received: 07/31/2015
Decision Date: 10/29/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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