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 patch, pledget and intracardiac, petp, ptfe, polypropylene
510(k) Number K041716
Device Name PTFE FELTS AND PLEDGETS
Applicant
BOSTON SCIENTIFIC CORP.
TWO SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact MAUREEN MONTBRIAND
Correspondent
BOSTON SCIENTIFIC CORP.
TWO SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact MAUREEN MONTBRIAND
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received06/24/2004
Decision Date 07/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-