FDA 510(k) Application Details - K920707

Device Classification Name Catheter, Peripheral, Atherectomy

  More FDA Info for this Device
510(K) Number K920707
Device Name Catheter, Peripheral, Atherectomy
Applicant DEVICES FOR VASCULAR INTERVENTION, INC.
595 PENOBSCOT DR.
REDWOOD CITY, CA US
Other 510(k) Applications for this Company
Contact KARL HALL
Other 510(k) Applications for this Contact
Regulation Number 870.4875

  More FDA Info for this Regulation Number
Classification Product Code MCW
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 02/18/1992
Decision Date 11/23/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact