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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name clamp, vascular
510(K) Number K122405
Model 0684-00-0572
Device Name AIR-BAND RADIAL COMPRESSION DEVICE
Applicant
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 law dr.
fairfield,  NJ  07004 0011
Contact carla s cerqueira
Regulation Number870.4450
Classification Product Code
DXC  
Date Received08/07/2012
Decision Date 11/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-