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, Peripheral, Atherectomy
510(k) Number K920707
Device Name HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER
Applicant
Devices For Vascular Intervention, Inc.
595 Penobscot Dr.
Redwood City,  CA  94063
Applicant Contact KARL HALL
Correspondent
Devices For Vascular Intervention, Inc.
595 Penobscot Dr.
Redwood City,  CA  94063
Correspondent Contact KARL HALL
Regulation Number870.4875
Classification Product Code
MCW  
Date Received02/18/1992
Decision Date 11/23/1992
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
-
-