510(k) Full Version – EXTENDED LIFE CAPD Transfer Set (K152675)

510(k) Full Version – EXTENDED LIFE CAPD Transfer Set (K152675)

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510(K) Number: K152675
Device Name: EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER
Manufacturer: BAXTER HEALTHCARE
Device Classification Name: Set, Administration, For Peritoneal Dialysis, Disposable
Regulation Number: 876.5630
Classification Product Code: KDJ
Date Received: 09/18/2015
Decision Date: 10/29/2015
Regulation Medical Specialty: Gastroenterology/Urology
Request Contents: Full version of 510(k) K152675 for EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER.
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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