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, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K860743
Device Name CAROTID BYPASS SHUNT WITH SAMPLING ARM
Applicant
Clincal Instruments Corp.
9 Cross St.
Dudley,  MA  01570
Applicant Contact MICHAEL L POLANYI
Correspondent
Clincal Instruments Corp.
9 Cross St.
Dudley,  MA  01570
Correspondent Contact MICHAEL L POLANYI
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/27/1986
Decision Date 05/28/1986
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
-
-