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510(k) K120337

I-PORT ADVANCE INJECTION PORT by Unomedical A/S — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2012
Date Received
February 3, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

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

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