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 set, administration, intravascular
510(k) Number K941190
Device Name CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET
Applicant
ICU MEDICAL, INC.
142 TECHNOLOGY DR.
IRVINE,  CA  92718
Applicant Contact SALVADORE PALOMARES
Correspondent
ICU MEDICAL, INC.
142 TECHNOLOGY DR.
IRVINE,  CA  92718
Correspondent Contact SALVADORE PALOMARES
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/14/1994
Decision Date 01/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-