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510(k) K110214

DIRECTVISION CATHETER, UNCOATED by Percuvision — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2011
Date Received
January 25, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Percuvision

  • K091600 — DIRECTVISION GUIDE SYSTEM (August 25, 2009)
  • K090262 — PERCUCATH URINARY CATHETER (May 28, 2009)

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