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, Percutaneous
510(k) Number K881793
Device Name WILSON BIOMEDICAL CORONARY GUIDING CATHETER
Applicant
Wilson Biomedical, Inc.
1 Airport Industrial Park,
Rd. 1
Glens Falls,  NY  12801
Applicant Contact NORMAN L HALL
Correspondent
Wilson Biomedical, Inc.
1 Airport Industrial Park,
Rd. 1
Glens Falls,  NY  12801
Correspondent Contact NORMAN L HALL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/26/1988
Decision Date 10/19/1988
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
-
-