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510(k) K041338

Device
MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
Applicant
MEDTRONIC VASCULAR
510(k) number
K041338
Product code
MWS  
Decision
Substantially Equivalent (SESE)
Decision date
2004-07-19
Date received
2004-05-20
Regulation
870.4500
Classification name
Stabilizer, Heart
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SCOTT CUNDY
Address
7601 Northland Dr. Brooklyn Park MN US 55428 55428

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MWS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992476PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADSPilling Weck Surgical2000-09-13
K992833VACUUM ASSIST STABILIZERCardio Thoracic Systems1999-11-10
K982419HEART-LIFT BALLOON POSITIONERCardiothoracic Systems, Inc.1999-01-13

Legacy Summary#

summary

FDA Review#

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