VERSA-CATH ARTERIAL CATHETER

Catheter, Embolectomy

IDEAS FOR MEDICINE, INC.

The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Versa-cath Arterial Catheter.

Pre-market Notification Details

Device IDK961883
510k NumberK961883
Device Name:VERSA-CATH ARTERIAL CATHETER
ClassificationCatheter, Embolectomy
Applicant IDEAS FOR MEDICINE, INC. 12167-49TH.STREET NORTH Pinellas Park,  FL  33520
ContactElizabeth M Paul
CorrespondentElizabeth M Paul
IDEAS FOR MEDICINE, INC. 12167-49TH.STREET NORTH Pinellas Park,  FL  33520
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-15
Decision Date1997-01-13
Summary:summary

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