510(k) K081420

VANISHPOINT I.V. CATHETER by Retractable Technologies, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2008
Date Received
May 20, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

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