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 Wire, Guide, Catheter
510(k) Number K863178
Device Name UMI STEERABLE TORQUE GUIDE WIRE
Applicant
Universal Medical Instrument Corp.
Post Office Box 100
Ballston Spa,  NY  12020
Applicant Contact CHARLES COPPERBERG
Correspondent
Universal Medical Instrument Corp.
Post Office Box 100
Ballston Spa,  NY  12020
Correspondent Contact CHARLES COPPERBERG
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/18/1986
Decision Date 09/19/1986
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
-
-