24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524

Catheter, Steerable

MEDTRONIC CARDIAC SURGICAL PRODUCTS

The following data is part of a premarket notification filed by Medtronic Cardiac Surgical Products with the FDA for 24 Fr. Left Heart Vent Catheter With Pressure Monitoring Line, Model 12524.

Pre-market Notification Details

Device IDK012143
510k NumberK012143
Device Name:24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
ClassificationCatheter, Steerable
Applicant MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON SW Grand Rapids,  MI  49504 -6393
ContactMelissa Harriger
CorrespondentMelissa Harriger
MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON SW Grand Rapids,  MI  49504 -6393
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-10
Decision Date2001-10-24
Summary:summary

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