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 Fab, Rhodamine, Antigen, Antiserum, Control
510(k) Number K022067
Device Name CONVOY ADVANCED DELIVERY SHEATH
Applicant
Boston Scientific
2710 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact ANDREA L RUTH
Correspondent
Boston Scientific
2710 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact ANDREA L RUTH
Regulation Number866.5520
Classification Product Code
DBY  
Date Received06/25/2002
Decision Date 09/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-