PERCUTANEOUS CATHETER INTRODUCER

Introducer, Catheter

ALVA MEDICAL, INC.

The following data is part of a premarket notification filed by Alva Medical, Inc. with the FDA for Percutaneous Catheter Introducer.

Pre-market Notification Details

Device IDK800580
510k NumberK800580
Device Name:PERCUTANEOUS CATHETER INTRODUCER
ClassificationIntroducer, Catheter
Applicant ALVA MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-14
Decision Date1980-04-02

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