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 K855061
Device Name CURITY PERCUTANEOUS CATHETER INSERTION KIT
Applicant
The Kendal Co.
One Federal St.
Boston,  MA  02110
Applicant Contact MARK W WENZELL
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110
Correspondent Contact MARK W WENZELL
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/18/1985
Decision Date 04/16/1986
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
-
-