FDA 510(k) Application Details - K964112

Device Classification Name Device, Vascular, For Promoting Embolization

  More FDA Info for this Device
510(K) Number K964112
Device Name Device, Vascular, For Promoting Embolization
Applicant TARGET THERAPEUTICS
47201 LAKEVIEW BLVD.
P.O. BOX 5120
FREEMONT, CA 94538 US
Other 510(k) Applications for this Company
Contact LARAINE PANGELINA
Other 510(k) Applications for this Contact
Regulation Number 870.3300

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

  More FDA Info for this Product Code
Date Received 10/15/1996
Decision Date 02/26/1997
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