FDA 510(k) Application Details - K950352

Device Classification Name Wire, Guide, Catheter

  More FDA Info for this Device
510(K) Number K950352
Device Name Wire, Guide, Catheter
Applicant BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN, MA US
Other 510(k) Applications for this Company
Contact MARY P LEGRAW
Other 510(k) Applications for this Contact
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 01/30/1995
Decision Date 04/28/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee NE - Neurology
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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