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 Transducer, Pressure, Catheter Tip
510(k) Number K140466
Device Name PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300
Applicant
St. Jude Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE SE-751 35
Applicant Contact Jeffrey Roberts
Correspondent
St. Jude Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE SE-751 35
Correspondent Contact ANNA-LISA TIENSUU
Regulation Number870.2870
Classification Product Code
DXO  
Subsequent Product Codes
DQX   DRG  
Date Received02/24/2014
Decision Date 11/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-