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510(k) K210544

Medtronic Extended infusion set by Unomedical A/S — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2021
Date Received
February 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K160648 — MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (August 10, 2016)
  • K132142 — NERIA SOFT 90 INFUSION SET (October 8, 2013)
  • K120337 — I-PORT ADVANCE INJECTION PORT (February 16, 2012)
  • K070430 — PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS (April 4, 2007)
  • K061374 — INTUITION INFUSION SETS (July 31, 2006)
  • K051264 — COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS (September 1, 2005)
  • K041545 — CONTACT DETACH (June 30, 2004)

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