TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Tubing And Connectors With Trillium Biopassive Surface.

Pre-market Notification Details

Device IDK012538
510k NumberK012538
Device Name:TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis,  MN  55428
ContactMarie Holm
CorrespondentMarie Holm
MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-07
Decision Date2001-08-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20721902350089 K012538 000

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