• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name catheter, intravascular, diagnostic
510(k) Number K942927
Device Name 0.035 IN. WISE WIRE
Original Applicant
BOSTON SCIENTIFIC CORP.
480 pleasant st.
watertown,  MA  02472 -2407
Original Contact christine m harris
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/22/1994
Decision Date 06/13/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-