MODIFICATION TO SHORT INTRODUCER SHEATH

Introducer, Catheter

REX MEDICAL LP

The following data is part of a premarket notification filed by Rex Medical Lp with the FDA for Modification To Short Introducer Sheath.

Pre-market Notification Details

Device IDK042399
510k NumberK042399
Device Name:MODIFICATION TO SHORT INTRODUCER SHEATH
ClassificationIntroducer, Catheter
Applicant REX MEDICAL LP 55 Northern Blvd. Suite 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
REX MEDICAL LP 55 Northern Blvd. Suite 200 Great Neck,  NY  11021
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-03
Decision Date2004-12-17
Summary:summary

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