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 system, balloon, intra-aortic and control
510(k) Number K120868
Device Name MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
Applicant
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 LAW DR.
FAIRFIELD,  NJ  07004 -0011
Applicant Contact HELDER A SOUSA
Correspondent
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 LAW DR.
FAIRFIELD,  NJ  07004 -0011
Correspondent Contact HELDER A SOUSA
Regulation Number870.3535
Classification Product Code
DSP  
Date Received03/22/2012
Decision Date 04/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-