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 Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K132567
Device Name ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN
Applicant
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact DOLLY MISTRY
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact DOLLY MISTRY
Regulation Number880.5970
Classification Product Code
LJS  
Subsequent Product Code
FOZ  
Date Received08/15/2013
Decision Date 11/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-