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510(k) K141146

INVISIPORT by Stealth Therapeutics, Incorporated — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2015
Date Received
May 5, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Stealth Therapeutics, Incorporated

  • K110407 — INVISIPORT (October 13, 2011)

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