DUAL BALLOON EMBOLECTOMY CATHETER

Catheter, Embolectomy

IDEAL MEDICAL, INC.

The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Dual Balloon Embolectomy Catheter.

Pre-market Notification Details

Device IDK914880
510k NumberK914880
Device Name:DUAL BALLOON EMBOLECTOMY 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 Received1991-10-30
Decision Date1992-03-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.