CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)

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 Change Of Catheter Body Material (radio-opaque Ny).

Pre-market Notification Details

Device IDK872485
510k NumberK872485
Device Name:CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
ClassificationCatheter, Embolectomy
Applicant IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
ContactMark R Waddell
CorrespondentMark R Waddell
IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-22
Decision Date1987-08-12

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