FDA 510(k) Application Details - K972142

Device Classification Name Wire, Guide, Catheter

  More FDA Info for this Device
510(K) Number K972142
Device Name Wire, Guide, Catheter
Applicant GUIDANT CORP.
26531 YNEZ RD.
PO BOX 9810
TEMECULA, CA 92591-4628 US
Other 510(k) Applications for this Company
Contact WAYNE R HOHMAN
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 06/06/1997
Decision Date 08/25/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
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