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510(k) K220632

Boss Crossing Support Catheter by Marvao Medical Devices, Ltd. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2022
Date Received
March 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • K161026 — NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 c (August 9, 2016)
  • K143567 — NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD (March 31, 2015)
  • K140492 — NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE (November 13, 2014)
  • K133796 — NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIAL (January 31, 2014)
  • K121933 — NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSI (March 14, 2013)
  • K110627 — NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER (August 12, 2011)

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