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510(k) K110407

INVISIPORT by Stealth Therapeutics, Incorporated — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2011
Date Received
February 14, 2011
Clearance Type
Traditional
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

  • K141146 — INVISIPORT (May 1, 2015)

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