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 K893243
Device Name INTRA AORTIC BALLOON
Applicant
DATASCOPE CORP.
3 FIR CT.
P.O. BOX 3100
OAKLAND,  NJ  07436
Applicant Contact PAUL SCHNEIDER
Correspondent
DATASCOPE CORP.
3 FIR CT.
P.O. BOX 3100
OAKLAND,  NJ  07436
Correspondent Contact PAUL SCHNEIDER
Regulation Number870.3535
Classification Product Code
DSP  
Date Received06/01/1989
Decision Date 06/20/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-