INTRAVASCULAR ACCESS INTRODUCER SHEATH

Introducer, Catheter

APPLIED MEDICAL RESOURCES CORP.

The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Intravascular Access Introducer Sheath.

Pre-market Notification Details

Device IDK041506
510k NumberK041506
Device Name:INTRAVASCULAR ACCESS INTRODUCER SHEATH
ClassificationIntroducer, Catheter
Applicant APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactCheryl Blake
CorrespondentCheryl Blake
APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-07
Decision Date2004-10-15
Summary:summary

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