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510(k) K200373

Deltaven Fast Flash Closed I.V. Catheter Systems by Delta Med Spa — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2020
Date Received
February 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Delta Med Spa

  • K171530 — Deltaven XiV Max, Deltaven XiV Max FF (December 21, 2017)
  • K140175 — INTRAVASCULAR ADMINISTRATION SET (August 5, 2014)
  • K121007 — NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA S (December 28, 2012)

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