VANISHPOINT I.V. CATHETER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

RETRACTABLE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Vanishpoint I.v. Catheter.

Pre-market Notification Details

Device IDK081420
510k NumberK081420
Device Name:VANISHPOINT I.V. CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm,  TX  75068 -0009
ContactRhonda Wells
CorrespondentRhonda Wells
RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm,  TX  75068 -0009
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-20
Decision Date2008-11-07
Summary:summary

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