PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS

Catheter, Continuous Flush

CORDIS NEUROVASCULAR, INC.

The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Prowler Infusion Catheters With Pre-shaped Tips.

Pre-market Notification Details

Device IDK003925
510k NumberK003925
Device Name:PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
ClassificationCatheter, Continuous Flush
Applicant CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes,  FL  33014
ContactAmarilys Machado
CorrespondentAmarilys Machado
CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes,  FL  33014
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-20
Decision Date2001-01-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704028765 K003925 000
10886704028628 K003925 000
10886704028611 K003925 000
10886704028604 K003925 000
10886704028598 K003925 000
10886704028581 K003925 000
10886704028574 K003925 000
10886704028550 K003925 000
10886704028543 K003925 000
10886704028536 K003925 000
10886704028529 K003925 000
10886704028635 K003925 000
10886704028642 K003925 000
10886704028659 K003925 000
10886704028758 K003925 000
10886704028741 K003925 000
10886704028734 K003925 000
10886704028727 K003925 000
10886704028710 K003925 000
10886704028703 K003925 000
10886704028697 K003925 000
10886704028680 K003925 000
10886704028673 K003925 000
10886704028666 K003925 000
10886704028512 K003925 000

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