Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Catheter, Percutaneous
510(k) Number K032622
Device Name ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
Applicant
Medtronic Vascular
7000 Central Ave. N.
Fridley,  MN  55432 -3576
Applicant Contact LYNN JENSEN
Correspondent
Medtronic Vascular
7000 Central Ave. N.
Fridley,  MN  55432 -3576
Correspondent Contact LYNN JENSEN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/26/2003
Decision Date 09/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-