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 Cannula, Catheter
510(k) Number K902674
Device Name DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
Applicant
Datascope Corp.
3 Fir Ct.
P.O. Box 3100
Oakland,  NJ  07436
Applicant Contact ROBERT B SCHOCK,PHD
Correspondent
Datascope Corp.
3 Fir Ct.
P.O. Box 3100
Oakland,  NJ  07436
Correspondent Contact ROBERT B SCHOCK,PHD
Regulation Number870.1300
Classification Product Code
DQR  
Date Received06/18/1990
Decision Date 01/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-