ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID

Catheter, Percutaneous

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Attain Lds 6216a Left Heart Delivery System, Attain Access 6218a Left Heart Delivery System, Attain 6216a And 6218a Guid.

Pre-market Notification Details

Device IDK112917
510k NumberK112917
Device Name:ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
ClassificationCatheter, Percutaneous
Applicant MEDTRONIC, INC. 8200 CORAL SEA STREET MS MVS11 Mounds View,  MN  55112
ContactDeborah Kidder
CorrespondentDeborah Kidder
MEDTRONIC, INC. 8200 CORAL SEA STREET MS MVS11 Mounds View,  MN  55112
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-03
Decision Date2011-10-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994951915 K112917 000
00613994951908 K112917 000
00613994951892 K112917 000
00613994951885 K112917 000
00613994951878 K112917 000
00613994951861 K112917 000
00613994951847 K112917 000
00613994951830 K112917 000

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