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 Introducer, Catheter
510(k) Number K003889
Device Name ANCURE SHEATH MODEL # 40315, 40320, 40325
Applicant
Guidant Cardiac and Vascular Surgery
1525 O'Brien Dr.
Menlo Park,  CA  94025
Applicant Contact JACQUELINE J JACKSON
Correspondent
Guidant Cardiac and Vascular Surgery
1525 O'Brien Dr.
Menlo Park,  CA  94025
Correspondent Contact JACQUELINE J JACKSON
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/18/2000
Decision Date 01/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-