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, Short-Term Less Than 30 Days
510(k) Number K974543
Device Name L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER
Applicant
LUTHER MEDICAL PRODUCTS, INC.
530 KINGS RD.
NEWPORT BEACH,  CA  92663 -5710
Applicant Contact BARBARA C LUTHER
Correspondent
LUTHER MEDICAL PRODUCTS, INC.
530 KINGS RD.
NEWPORT BEACH,  CA  92663 -5710
Correspondent Contact BARBARA C LUTHER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/03/1997
Decision Date 02/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-