TRI-LUMEN INTRA VASCULAR BALLOON CATHETER

Catheter, Embolectomy

IDEAL MEDICAL, INC.

The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Tri-lumen Intra Vascular Balloon Catheter.

Pre-market Notification Details

Device IDK891021
510k NumberK891021
Device Name:TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
ClassificationCatheter, Embolectomy
Applicant IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
ContactLorna K Linville
CorrespondentLorna K Linville
IDEAL MEDICAL, 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 Received1989-02-28
Decision Date1989-09-18

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