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 K915553
Device Name USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING
Applicant
C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
P.O. BOX 7025
BILLERICA,  MA  01821
Applicant Contact PATRICIA W FRYDRYCK
Correspondent
C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
P.O. BOX 7025
BILLERICA,  MA  01821
Correspondent Contact PATRICIA W FRYDRYCK
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/11/1991
Decision Date 02/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-