ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER

Catheter, Umbilical Artery

SHERWOOD MEDICAL CO.

The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Neo-sert Triple Lumen Umbilical Vessel Catheter.

Pre-market Notification Details

Device IDK951738
510k NumberK951738
Device Name:ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER
ClassificationCatheter, Umbilical Artery
Applicant SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis,  MO  63103 -1625
ContactDennis Pozzo
CorrespondentDennis Pozzo
SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis,  MO  63103 -1625
Product CodeFOS  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-14
Decision Date1995-09-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884527005208 K951738 000
10884527005192 K951738 000

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