FDA 510(k) Application Details - K821190

Device Classification Name Wire, Guide, Catheter

  More FDA Info for this Device
510(K) Number K821190
Device Name Wire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 LAKESIDE DR.
SANTA CLARA, CA US
Other 510(k) Applications for this Company
Regulation Number 870.1330

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

  More FDA Info for this Product Code
Date Received 04/27/1982
Decision Date 08/31/1982
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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