VESSEL DILATOR AND INTRODUCER SHEATH

Dilator, Vessel, For Percutaneous Catheterization

IDEAL MEDICAL, INC.

The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Vessel Dilator And Introducer Sheath.

Pre-market Notification Details

Device IDK882238
510k NumberK882238
Device Name:VESSEL DILATOR AND INTRODUCER SHEATH
ClassificationDilator, Vessel, For Percutaneous Catheterization
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 CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-27
Decision Date1988-08-25

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