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 K970864
FOIA Releasable 510(k) K970864
Device Name ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
Applicant
ARROW INTL., INC.
3000 BERNVILLE RD.
READING,  PA  19605
Applicant Contact THOMAS D NICKEL
Correspondent
ARROW INTL., INC.
3000 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact THOMAS D NICKEL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/10/1997
Decision Date 10/17/1997
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
Recalls CDRH Recalls
-
-